Daily Health Headlines

FDA's Cancer-Drug Reviewers Often Join Industry Later: Study

👤by Karen Pallarito 0 comments 🕔Wednesday, September 28th, 2016

TUESDAY, Sept. 27, 2016 (HealthDay News) -- Among federal employees who review new cancer-drug applications for the U.S. Food and Drug Administration, about half who leave to work elsewhere end up working for the industry they once regulated.

That's what researchers at Oregon Health and Science University (OHSU) concluded after following the career paths of 55 FDA reviewers of new blood and cancer drugs.

The findings raise concerns about regulators' ability to make impartial decisions in the public interest, the researchers suggest.

"If you left the FDA, 57.7 percent of the time you worked for and consulted for the industry," said Dr. Vinay Prasad, a hematologist-oncologist and assistant professor of medicine.

"It's astonishingly high," added Prasad, a co-author of a letter that addresses the issue and was published Sept. 27 in the BMJ.

Concerns about the "revolving door" between government and industry aren't new.

According to Dr. Michael Carome, director of Public Citizen's health research group, "We've said for years ... that the FDA has grown too cozy with industry." Public Citizen is a nonprofit consumer rights advocacy organization.

"I doubt this is unique to the hematology-oncology division," Carome added.

Not that FDA cancer drug reviewers are doing anything illegal by taking industry jobs after leaving the government. As FDA employees, they must adhere to conflict-of-interest rules and violators may be subject to criminal prosecution, Carome noted.

The question, Prasad said, is whether drug reviewers are succumbing to subtle, even subconscious, pressures to approve drugs, thinking someday they might want to work for industry.

The reality is that cancer drug reviewers, whose starting pay at the FDA is "something like $170,000 to $190,000 a year," can earn substantially more in industry, Prasad said.

Perhaps that's so, but the FDA tries to stem that line of thinking, an agency spokesman said.

"The FDA has a strong set of rules in place to ensure that our employees are working in the public interest, not to the advantage of any company, organization or individual," said Jason Young, acting assistant commissioner for media affairs at the FDA.

Federal laws and FDA ethics rules cover a range of issues, including conflicts, disclosures and confidentiality of information they [former employees] worked on while employees, Young said. There's also a "cooling-off requirement" for senior employees and other "rules against switching sides, contacting former employees and contacting agency leaders," he said.

Using the FDA drug database, Prasad and co-author Jeffrey Bien, also of OHSU, identified 55 people who reviewed new applications for cancer and blood disease treatments from 2001 to 2010.

Then using publicly available information, they matched those individuals to the jobs they subsequently held.

Roughly half stayed at the FDA and half left, the investigators found. Of the 26 who moved on, 15 landed in jobs working or consulting for the biopharmaceutical industry.

In percentage terms, that means nearly 58 percent of those who left the FDA for another job took industry positions, the findings showed.

Researchers were unable to document the whereabouts of 30 percent of the former FDA employees except to say eight no longer worked for the U.S. Department of Health and Human Services, which oversees the FDA.

If anything, the study authors said, the extent of the government-to-industry phenomenon is underestimated since not all reviewers' future careers could be identified.

"They have a right to leave," Carome said. "I don't think that can ever be banned."

Article Credits / Source

Karen Pallarito / HealthDay

Karen Pallarito wrote this story for HealthDay. HealthDay provides up to the minute breaking health news. Click here to view this full article from HealthDay.

SOURCES: Vinay Prasad, M.D., hematologist-oncologist and assistant professor, medicine, Oregon Health and Science University, Portland; Michael Carome, M.D., director, Public Citizen's Health Research Group, Washington, D.C.; Jason Young, acting assistant commissioner for media affairs, U.S. Food and Drug Administration; Sept. 27, 2016, BMJ

View More Articles From Karen Pallarito 🌎View Article Website

Sponsored Product

Lunar Sleep for $1.95

Lunar Sleep for $1.95

People who have trouble sleeping typically have low levels of melatonin, so melatonin supplements seem like a logical fix for insomnia. There is a high demand for sleep aids, especially in the U.S. The National Health Interview Survey done in 2002, and again in 2007, found 1.6 million US adults were using complementary and alternative sleep aids for insomnia. Lunar Sleep was a top choice. Use Promo Code: Sleep2014 and only pay $1.95 S&H.

Get Lunar Sleep for $1.95

More Cancer Articles

No Benefit From Routine Thyroid Cancer Screening: Task Force

No Benefit From Routine Thyroid Cancer Screening: Task Force0

TUESDAY, Nov. 22, 2016 (HealthDay News) -- Doctors should not screen for thyroid cancer in patients who have no symptoms of the disease, according to a U.S. Preventive Services Task Force draft recommendation. It reaffirms a recommendation ...

Depressed Women Less Likely to Get Best Breast Cancer Care: Study

Depressed Women Less Likely to Get Best Breast Cancer Care: Study0

FRIDAY, Nov. 18, 2016 (HealthDay News) -- Breast cancer patients with a history of depression are less likely to receive recommended care for their disease, a new study finds. The study included more than 45,000 Danish women diagnosed with ...

Earnings Fall After a Child's Cancer Diagnosis

Earnings Fall After a Child's Cancer Diagnosis0

MONDAY, Nov. 21, 2016 (HealthDay News) -- After a child's cancer diagnosis, parents' income often drops and mothers frequently stop working, a new study finds. Moreover, the financial effects of a cancer diagnosis can last years, with mothers' ...

Monoclonal Antibodies

Monoclonal Antibodies0

home / cancer center / cancer a-z list / monoclonal antibodies index / monoclonal antibodies drug monograph Pharmacy Author: Omudhome Ogbru, PharmD Omudhome Ogbru, PharmDDr. Ogbru received his ...

New Drug May Brighten Outlook for Advanced Breast Cancer

New Drug May Brighten Outlook for Advanced Breast Cancer0

WEDNESDAY, Nov. 16, 2016 (HealthDay News) -- A recently approved drug can help slow the progression of advanced breast cancer, a new clinical trial confirms. The drug, called palbociclib (Ibrance), was approved in the United States last year ...

View More Cancer Articles

0 Comments

Write a Comment

Your email address will not be published. Required fields are marked *

Our Mailing List

Subscribe to our mailing list to get the latest health news as it breaks!

Your information will not be shared with anyone!