In the months before the U.S. Food and Drug Administration did an about-face on diet drugs, agency officials participated in a series of meetings at George Washington University.
Among the others in attendance: Drug companies, weight-loss clinics, medical societies and academic physicians specializing in weight loss — what Diana Zuckerman, president of the National Center for Health Research, calls the “weight-loss industrial complex.”
The aim: Get new diet drugs on the market.
The group even produced a 24-page report — Obesity Drug Outcome Measures — that encouraged the goal.
“The one thing they all had in common: They needed products to sell,” said Zuckerman, who attended the meetings, which were financed in large part by drug companies.
In all, drug companies have spent more than $60 million in lobbying and other payments since 2010, when they began an intense push to get new diet drugs on the market, a Milwaukee Journal Sentinel/MedPage Today investigation found.
Much of their effort was aimed at convincing the FDA to start approving new diet drugs again, despite decades of harm caused by diet pills found to be unsafe after approval in the past.
Money also was used to lobby Congress, which prodded the agency to start approving the new products. And money was given to medical groups and doctors that encouraged use of diet pills.
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 Journal Sentinel/MedPage Today review only examined money spent since 2010. That’s when a push to get new diet drugs approved began from drug-makers Orexigen, Takeda, Eisai, Arena, Vivus, Novo Nordisk and Shire Pharmaceuticals.
In the wake of the spending, the FDA — which had not approved a new diet drug for 13 years — has allowed five potentially harmful products on the market in the last three years, including two in the last four months.
Three of the drugs had previously been rejected by the agency.
With an estimated 35% of adult Americans being obese, according to the U.S. Centers for Disease Control and Prevention, the FDA’s switch opens a potentially lucrative revenue stream for the drug companies.
“They spend a lot of money and time lobbying for their cause,” said Jeanmarie Perrone, a medical doctor and drug safety researcher at the University of Pennsylvania who was on an FDA advisory committee for the diet drug Belviq and voted against its approval.
“I can’t believe the number of conflicts of interest I see, even in academia, around these issues,” she said. “It is really hard to find an uninterested person.”
Perrone said she opposed approval for several reasons, including concerns about potential cancer risk and heart valve damage, and because many of those in the clinical trial gained back weight after they stopped using the drug.
Public health, private enterprise
The latest diet drug push was propelled with a fusion of public health, private enterprise and politics — and plenty of drug company money.
In 2010, the FDA rejected two new diet drugs citing concerns about cardiovascular safety. Two months earlier, the agency had removed the drug Meridia from the market — a rare step. In doing so, the agency cited a just-completed clinical trial that had linked the drug to increased heart attacks and strokes.
Then, in the fall of 2011, the U.S. Senate stepped in.
Calling the “absence of novel medicines to treat obesity” a concern, the Senate Appropriations Subcommittee on Agriculture, which oversees FDA funding, directed the agency to report back on “steps it will take to support the development of new treatments for obesity.”
The agency responded three months later with a four-page report to the Senate, stating its commitment “to working with pharmaceutical companies to bring new obesity drugs with favorable benefit-risk profiles to the market.”
Within six months, new diet drugs started to come to market. First, Belviq was approved in June 2012. Then Qsymia was approved in July. Both had been rejected two years earlier.
A third previously-rejected drug, Contrave, would later win approved as well.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said the agency did not feel pressured by Congress to green light new diet drugs.
“There’s congressional pressure about everything, because they do constituent service, but that doesn’t affect our decisions,” she said.
Medical societies soon started to release first-ever guidelines on the treatment of obesity. The guidelines, which can have a major influence on how doctors make treatment decisions, called for treating obesity as a disease and described how diet drugs could be used to treat it.
In November 2013, the Obesity Society, in partnership with cardiovascular organizations, issued a guideline that urged doctors to diagnose and treat obesity at every clinic visit.
In the spring of 2014, the American Association of Clinical Endocrinologists released new recommendations for diagnosing and treating obesity. In 2012, the group had released a position statement on obesity that urged clinicians to recognize obesity as a disease.
And earlier this year, the Endocrine Society released a guideline focusing on the use of drugs to treat obesity. It marked the first time any guideline made specific recommendations on the use of the new diet drugs.
Money to societies
Collectively, the medical societies have received at least $4 million from companies that manufacture diet drugs.
According to records provided by the Obesity Society, the group has received $393,000 in contributions from obesity drug-makers since 2011.
Drug companies also gave money to the popular ObesityWeek, a weeklong conference for doctors who treat obesity. The conference is presented by the society and the American Society for Metabolic and Bariatric Surgery but is a separate entity.
Eisai, the maker of Belviq, donated $300,000 to the 2013 and 2014 ObesityWeek events, according to information from the Obesity Society. Vivus, Takeda and Novo Nordisk each gave at least $200,000 to the conferences.
In a statement, the Obesity Society said its relationships with industry “have furthered the Society and our members in seeking meaningful, evidence-based solutions for obesity” and that its policy is to keep those relationships transparent, including posting them on its website.
Meanwhile, the endocrinologists’ association received $3.2 million from obesity drug-makers in 2013, according to federal tax filings. That accounted for nearly 30% of its 2013 revenue of $11 million.
The group has spent $400,000 lobbying Congress since 2010, mostly on issues related to diabetes, which is closely tied to obesity, according to data from the Clerk of the House of Representatives and Secretary of the Senate.
Association president R. Mack Harrell said in an email that “there is no inherent conflict of interest in the working relationship of physicians with industry and government. Rather, it is a commonality of interest that is healthy, desirable, and beneficial.”
The Endocrine Society — a separate physician group for endocrinologists — would not reveal how much money it has received from obesity drug companies, and the information was not clear from publicly-filed tax records. However, its website lists three diet-drug companies — Eisai, Novo Nordisk and Takeda — as 2014 and 2015 corporate contributors.
The organization has spent at least $750,000 on lobbying.
In a statement, the group said it “takes conflicts of interest very seriously” and has a “firewall” preventing industry financial support from having any affect on guidelines, noting that conflicts of interest among members of its guideline writing committee are reviewed and members can recuse themselves.
Payments to doctors
Millions more from diet drug companies went directly to doctors.
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. Meanwhile, Qsymia makers spent $1 million in that same period.
The publicly-available data only covers that period, which is before the other three drugs were approved.
The Open Payments system was created as part of the Affordable Care Act in the wake of media reports that exposed financial conflicts among drug companies and doctors as well as U.S. Justice Department investigations into unethical drug company behavior.
In the case of the just-released treatment guidelines from the Endocrine Society, the chair of the panel was Caroline Apovian.
She 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.
Open Payments data shows she received at least $31,000 in travel, food and speaking fees from diet drug-makers in the last five months of 2013.
Apovian has leadership positions with two different organizations that get funding from diet drug companies. She is chairwoman of the Endocrine Society and a board member of the Obesity Society.
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 “time, travel and expenses.” She said she is transparent about the money she receives.
“Despite the growing problem of obesity in this country,” Apovian said, “there are still very few qualified experts in the field today.”
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.
One of the panel members did not disclose his payments from drug companies. Christopher Still received more than $40,000 from Eisai and Vivus in 2013 and worked as a speaker and consultant for Novo Nordisk and Takeda in 2014. After the omission was pointed out by reporters, the society said Still had filed an updated disclosure statement.
The diet drug companies spent $19.7 million — more than a third of their lobbying total — in 2011 and 2012, the period when the FDA began approving diet drugs again.
Since then, the lobbying money has continued to flow, with more than $22 million spent in the last two full years.
Eisai, which markets Belviq, said in a statement that it is currently lobbying for the Treat and Reduce Obesity Act in order to educate members of Congress about the obesity epidemic. A primary focus of that legislation is to get Medicare to cover obesity drugs.
Qsymia drug-maker Vivus said in a statement that the company “has invested funds in the normal course of acceptable business practice as set forth by federal reporting guidelines.”
Saxenda drug-maker Novo Nordisk “advocates on industry issues of impact to our patients and business,” said company spokeswoman Marisa Sharkey. She said the company “strenuously advocates for legislation and regulatory action impacting people with diabetes, hemophilia and growth deficiencies.”
Shire Pharmaceuticals spokeswoman Gwen Fisher said the company has never lobbied Congress on behalf of Vyvanse, a drug approved to treat binge eating disorder. Nor has it lobbied on the condition itself.
“We adhere to the highest of ethical standards and abide by all legal and regulatory requirements,” Fisher said in an email.
The meetings at George Washington University — which included regulators, drug-makers and weight-loss physicians — were held between November 2011 and July 2012. Financing came from five diet drug manufacturers.
A George Washington spokeswoman declined to say how much money the companies provided.
But Scott Kahan, a physician and weight-loss expert with the university, estimated the cost was about $200,000. He said drug companies paid most of that.
Kahan said in his view there was no conflict in accepting drug company funding.
Zuckerman, president of the National Center for Health Research, said the meetings underscored industry’s influence on the approval process. The organization is a nonpartisan group that promotes health and safety, including working to get unsafe medicines removed from the market.
“There was enormous pressure on the FDA to approve weight-loss products,” said Zuckerman. “In response, the FDA had an apparent change of heart and started approving drugs with very little benefit and substantial risk.”
John Fauber is a reporter with the Journal Sentinel. Coulter Jones and Kristina Fiore are reporters with MedPage Today. This story was reported as a joint project of the Journal Sentinel and MedPage Today, which provides a clinical perspective for physicians on breaking medical news at medpagetoday.com.