FDA and Pharma: Emails Raise Pay-for-Play Concerns

October 10, 2013

(MED PAGE) –   For more than a decade representatives of some of the nation’s leading pharmaceutical companies paid entry fees running into the tens of thousands of dollars to attend invitation only conferences with FDA and NIH officials, according to a trove of emails provided to the Milwaukee Journal Sentinel/MedPage Today.


42103The emails, most of which track correspondence among founders of an organization called IMMPACT, academics, NIH researchers, and FDA officials, raise serious questions about the way in which federal regulators interact with the pharmaceutical companies they regulate.

Entry to these meetings was secured by annual fees that ranged as high as $35,000. The drug companies that paid those fees were guaranteed the right to send a representative to the annual meetings of the organization known as IMMPACT, meetings that were also attended by officials from the FDA and other federal agencies..

The IMMPACT web site, states that the organization’s goal is to improve the design of clinical trials conducted to develop new pain treatments.

But the emails raise concerns about a possible pay-for-play arrangement in which drug companies were able to buy access to invitation-only meetings where they could meet with FDA officials and possibly influence FDA policy regarding approval and regulation of analgesics, said Michael Carome, MD, director of the health research group of the watchdog group, Public Citizen.

“The whole picture is a troubling one and it warrants an independent investigation,” said Carome, who has seen the emails.


As an example of an initiative that sprung from the IMMPACT meetings, Carome singled out the FDA’s new “enriched enrollment” guidance for conducting pivotal trials of drugs. Enriched enrollment allows drug companies to weed out nonresponders or subjects who have adverse reactions to the drug from enrollment in clinical trials.

Experts say that approach makes it much more likely a drug will prove effective and possibly win FDA approval. It’s also cheaper for drug companies to conduct such trials.

However, the approach has drawn criticism because it essentially stacks the deck in favor of the drug. More importantly, experts say, drugs tested that way are not likely to reflect what will happen when a drug gets on the market and is prescribed for large numbers of people.

“It’s in fact cheating,” said Patrick McGrath, PhD, a pediatric pain expert at the Dalhousie University in Halifax, Nova Scotia.

On its web site, the FDA says that enriched enrollment is potentially powerful strategy for the pharmaceutical industry because when used appropriately it can result in smaller studies, shortened drug development time and lower development costs.

While enrichment won’t save a drug that doesn’t work, it will help find one that will,” Bob Temple, MD, the agency’s deputy director for clinical science, wrote in a piece posted on the FDA’s web site last December.


The emails represent another example of how drug company money has influenced the practice of American medicine, a concern that has been raised in ongoing investigative reports in the Journal Sentinel/MedPage Today over the last 4 years. Several of those stories revealed how companies that make opioid analgesics funded various nonprofit organizations that advocated for expanded use of opioids, particularly in treating chronic pain. That increased use of opioids over more than a decade has been linked to an epidemic of overdose deaths and addiction. Last year, the U.S. Senate Committee on Finance, citing reports in the Journal Sentinel/MedPage Today, opened an investigation into those financial relationships.

The IMMPACT emails, which run for 409 pages, were obtained through a public records request by Craig Mayton, a Columbus, Ohio attorney who has made claims against drug companies in cases where people have died of opioid overdoses. The emails were provided to Mayton by the University of Washington where, Dennis Turk, PhD, one of the founders of the organization, works as a professor of anesthesiology and pain medicine.  Mayton gave the emails to the Journal Sentinel/MedPage Today.

In an email response to questions about the emails, FDA spokesman Steven Immergut, said the agency was aware of concerns raised about the agency’s involvement in the IMMPACT organization and

“we take these concerns very seriously. We are unaware of any improprieties…”

In an interview, Douglas Throckmorton, MD, the FDA’s deputy director for regulatory programs, said FDA officials who attended the organization’s meetings were listening to scientists, not setting policy.

“Pay-for-play is just not the way the FDA operates,” Throckmorton said. “That’s not part of the culture of the FDA.”

He said that while enriched enrollment may have been discussed at the organization’s meetings, the FDA’s decision to endorse of the concept did not come entirely from the meetings.

The emails paint a picture of another way in which drug companies can exert influence on the practice of medicine. In a 2003 email, Raymond Dionne, an official with the National Institutes of Health, raised a concern about the closed, invitation-only nature of the organization’s meetings and suggested open meeting on the NIH campus.

The major advantage of having the meeting on the NIH campus would be the ability to open the meeting to all interested parties and avoid the stigma that this initiative is a ‘pay to play’ process,” Dionne wrote.

A day later, Dionne wrote in an email that IMMPACT was inviting criticism that is it

“paid for by a few large pharmaceutical firms who are assumed to be influencing the outcomes.”


In another email about 2 weeks later, Dionne tells IMMPACT that he and other federal officials “if they play by the book” should not accept dinners for meetings at the Four Seasons Hotel.

“I may even bring a brown bag,” Dionne says.

In response, Robert Dworkin, PhD, the other co-founder of IMMPACT, told Dionne that, if he wished, the organization would order “inexpensive sandwiches for lunch for the government folks.”

The rest of us undoubtedly will feel guilty, but we will probably resist the temptation to have tuna fish in respect for your plight,” added Dworkin, a professor at the University of Rochester Medical Center.

Renate Myles, a spokeswoman for NIH, said that because of the federal government shut down she could not provide a response for this story.

Many of the academics invited to the organization’s meetings were offered payments of about $3,000 to attend. In a 2002 letter from Turk, the University of Washington professor who is a co-founder ofIMMPACT, a $3,000 honorarium was offered to Robert Rappaport, MD, who heads the FDA division that regulates analgesics, to attend an IMMPACT meeting in Annapolis, Md., The FDA said the payment was not accepted.

In an interview Turk, acknowledged that, dating back to 2002, drug companies paid between $20,000 and $35,000 each to be able to send one representative to the 16 meetings held by the group.

Nearly all the meetings were held over 2 days at high-end hotels in the Washington, D.C. area., Turk said.

Between 25 and 50 people, including regulators, academic researchers and drug company representatives attended each event.

“There was no attempt to do anything more than answer some questions,” Turk said.

After the meetings, consensus papers that listed drug company officials, federal health officials and academics as the co-authors were published in various medical journals.

Dworkin, said no more than than one person from any one drug company was allowed to attend the meetings and it was encouraged that companies send researchers, not marketing people.

Dworkin acknowledged that the emails might raise ethical concerns.

Yes, some of the emails that Dennis and I sent back and forth … looked problematic on the surface, but the fact of the matter is it was a model that worked that no one complained about,” said Dworkin, a professor and pain expert at the University of Rochester Medical Center.

The organization’s website lists 11 drug company sponsors, including several that make narcotic painkillers.

In an email, James Heins, a spokesman for Purdue Pharma, the company that makes the narcotic painkiller, OxyContin, said the pharmaceutical industry has been an important participant in the organization’s program.

“Our experience conducting clinical trials is valuable to academia and the FDA, especially in improving clinical trial design for analgesics,” Heins said.

In an email, Greg Panico, a spokesman for the Janssen Research & Development, said it funded the organization to help improve clinical trials involving pain drugs. Janssen’s, parent, Johnson & Johnson, is listed as a corporate sponsor on the organization’s web site.

“Our company believes in working collaboratively in public-private efforts to pursue scientific innovation,” Panico said.