In the early 1990s, the diet industry was under pressure.
Representative Ron Wyden began convening hearings in March 1990 titled “Deceptions and Fraud in the Diet Industry.”
Weight Watchers went from a profit of $45 million dollars in 1992 to a $50 million dollar loss in 1994. Jenny Craig’s earnings went down by 84 percent in 1993. NutriSystem declared bankruptcy in 1993. The FTC filed deceptive advertising claims against both Jenny Craig and Weight Watchers. (1)
This low point for the diet industry led to a sustained campaign of misinformation and stigmatization and led to a partnership between Weight Watchers style diet companies with pharmaceutical companies selling diet pills.
These partners used the same tactics oil companies would use to confuse the issue of climate change- lobbying members of Congress, funding fake “grassroots” campaigns, paying for scientists to write favorable papers to support them, placing members of their industry inside the regulatory and watchdog arms of the government.
The company selling diet pills was called Wyeth. And the diet pill was fen phen.
(Wyeth has many other names through different mergers and sales of the company, but to keep it simple, I’m going to just refer to them as Wyeth.)
We will be taking a deep dive into fen phen, because it is Wyeth’s campaign to have a version of fen phen called Redux approved by the FDA that set in motion an institutionalization of fat stigma as government policy, which we continue to see today.
Wyeth wanted to get into the business of selling diet drugs, specifically something they could combine with a drug they already had on the market called Pondimin, fenfluramine, the fen in fen phen. Pondimin worked partly by releasing serotonin into the bloodstream, the way SSRIs can work to treat depression. It’s major side effect was intense drowsiness. People couldn’t stay on the drug for very long because it caused them to sleep for 18 hours at a time.
Wyeth also had another drug that was very similar to Pondimin that they believed solved the drowsiness issue. It was called Redux, but it had not yet been approved by the FDA. (2)
The Food and Drug Administration was very hesitant at this time to approve drugs for weight loss. Many people were prescribed Dexedrine for weight loss in the 1930s — 1960s, which resulted in what came to be known as America’s first amphetamine epidemic.
Wyeth needed to overcome the FDA’s hesitance around diet drugs. They did this with a three pronged attack- pressure on the FDA by lobbying Congress, skewing the data on fen phen’s risks and side effects by hiding data and paying for bogus studies and papers, and by convincing the government and the public that being fat is a deadly disease killing hundreds of thousands of people every year.
Pressure on the FDA
When the Republicans took over the House in 1994, they were out for the FDA’s blood. With Newt Gingrich as Speaker, many of the FDA’s activities were privatized. Gingrich would even personally intervene in FDA decisions, pushing for the approval of the drugs for companies who had contributed to his foundation. (3)
In 1991, the FDA had drawn up a list of 111 ingredients used in non-prescription diet ads and declared them ineffective or unsafe. But in 1994, the Dietary Supplements Health and Education Act from Senator Orrin Hatch (R Utah), made it almost impossible for the FDA to continue regulating these products.
Instead of the manufacturers having to prove that their supplements are safe, now the FDA has to bear the burden of paying for an investigation to prove that these products are unsafe. (4)
“Officals now spoke of the pharmaceutical industry, not the American public, as ‘our clients’. Pharmaceuticals were playing hardball like doctors at the FDA had never seen before, backed by Congress. The FDA had to accede to the new culture, or its budget would be decimated.” (5)
Republicans even attempted to get rid of the FDA completely in 1994. While they were not successful in that attempt, the FDA’s budget has been cut again and again, while the balance is made up by “user fees” which are paid by the drug companies to the FDA for drug approval.
Add in the revolving door of officials at the FDA who leave the agency for lucrative jobs with the drug companies they are supposed to be regulating, and you can see that the agency is ripe for exploitation by the very industry it is supposed to be regulating.
What are the risks of fen phen and how did Wyeth hide those risks?
The biggest risk of fen phen is primary pulmonary hypertension (PPH). It is a heart and lung disorder that thickens the blood vessels that send oxygen to the lungs. It causes a slow and agonizing death from suffocation. PPH is a death sentence. Most patients only survive 2 years after the disease is diagnosed. The drug combo also caused damage to heart valves.
A study called the International Primary Pulmonary Hypertension Study (IPPHS) showed that while PPH affects only 1 or 2 people per million in a general population, with the use of fen phen, the number of patients increased by 10 times. (6)
This is for a drug where patients immediately regain any weight lost as soon as the drug is discontinued. And in a clinical trial, patients who took fen phen only lost 3 percent more weight than patients using a sugar pill. In a 200 pound person, 3 percent is 6 pounds. (7)
When attorneys for the massive fen phen civil lawsuit got access to Wyeth’s files during discovery, they found that the company had a list of 101 cases of PPH from the early 1990s to mid 1997. They had kept this information internal and had not provided it to either the FDA or doctors prescribing the drugs. (8)
Additionally, Wyeth was required to pass along any reports of negative reactions or problems occurring to fen phen patients. But when they filed their reports with the FDA, they re-labeled the heart valve damage and PPH as less serious issues, further misleading the regulators. (9)
How did Wyeth get these drugs approved?
In the hearings to get the Redux portion of fen phen approved, Wyeth cited the figure that 300,000 deaths per year were caused by “obesity”. They used this figure 7 times in the FDA hearings about the drug. (10)
“Using the risk-benefit analysis that Wyeth… had pushed at the FDA, the increased risks of PPH had been accepted only because the alleged benefits were even higher — saving many of the ubiquitous ‘300,000 deaths from obesity’.” (11)
Where did Wyeth get this figure from? No one seems to really know.
An internal Wyeth memo discovered during the civil trial referred to the number as having “never been substantiated”. (12)
The original source for the figure appears to be a study from 1993 by McGinnis and Foege, who stated in their research that the 300,000 deaths number was “due to poor diet and physical inactivity”, without mentioning body size. (13)
Even though this number morphed into an indictment of fat people, it is not clear how these figures were obtained, or how they determine that deaths were being caused by fatness, rather than simply that a fat person has died.
In critiquing a study from 1999 using the same 300,000 number, Glenn Gaesser has pointed out that because studies have repeatedly shown that there is no link between a higher BMI and death in people over 65, those people should be excluded from any claims about death due to fatness.
78 percent of the 2.3 million annual deaths in America are people over the age of 65. So that leaves about 500,000 deaths in people under 65 that might be related to fatness. So leaving out all other forms of death- car accidents, alcohol and cigarettes, drug abuse, homicide and suicide, toxic agents- 60% of all deaths in people under 65 would have to be caused by fatness. This is a flatly ridiculous and unbelievable claim. (14)
The 1999 study claiming 300,000 deaths from fatness states this clearly.
“Our calculations assume that all (controlling for age, sex, and smoking) excess mortality in obese people is due to their adiposity.”
“The authors of the study did not try to determine the extent to which… dieting, diet drugs, poverty, discrimination in healthcare, and social discrimination in general… accounted for some, most, or indeed quite possibly all of the excess mortality they observed among some groups of heavier people.” (15)
“They ‘discovered’ that all excess mortality among the heavier than average was caused by ‘excess’ weight simply by assuming this was the case!” (15)
Remember the discredited 400,000 deaths from fatness number put forward by the CDC in 2004? (16)
They keep trying this same trick.
Faking the Grassroots
Because of the risks of fen phen and doctors’ reluctance to prescribe medication for weight loss,Wyeth engaged in a campaign to convince the public that being fat was a deadly disease.
They were extremely successful and the consequences of this marketing effort remain with us to this day.
A number of public health focused “grassroots” organizations appeared in the early 1990s, funded by weight loss companies like Weight Watchers and by pharmaceutical companies, including Wyeth. (17)
One of those organizations was called Shape Up America!, a group founded by Surgeon General C. Everett Coop, which received $700,000 from Wyeth and appeared on The Brian Williams News Hour on MSNBC to tout fen phen as a solution for fatness. (18)
Shape Up America! also received funding from Jenny Craig, Weight Watchers, and NutriSystem, as well as the American Obesity Association, which is made up of bariatric (weight loss) surgeons. (19)
The executive director of Shape Up America! (who had formerly worked at Weight Watchers) apparently told the Surgeon General that the 300,000 deaths number was incorrect, but he kept using every time he spoke about the horrors of fatness, which was as often as he could. (20)
Wyeth also gave the American Obesity Association (AOA) $100,000 to publish “Guideline for Treatment of Adult Obesity”, which recommended fen phen to treat fatness. The AOA was also at the FDA hearings were the Redux portion of fen phen was approved and gave testimony advocating for it’s approval.
Wyeth also planned to lure writers for women’s magazines to conferences that they would sponsor, such as “Women and Obesity: An Epidemic of Denial.” The company’s PR experts wanted Wyeth to “motivate women to go to their doctor and ask about Redux.” They budgeted more than $21 million dollars for media in 1996, including $1.5 million for ads in medical journals and $179,000 for “Dear Doctor” announcements. (21)
The American Obesity Association’s “lobbying and advocacy efforts were primarily aimed at convincing the government to officially recognize obesity as a disease, getting more federal funding for obesity research, getting government programs like Medicare and Medicaid to pay for weight loss surgeries, changing tax laws to make the costs of weight loss programs like Jenny Craig and Weight Watchers tax deductible, and lobbying the insurance industry to cover weight loss treatments and drugs. In all of these areas, they have been successful.” (22)
These two groups, which should be understood as industry lobbying groups, were instead given non profit status and treated as neutral actors, which they were clearly not in any way.
Since being fat is now recognized as a disease by the American Medical Association and weight loss was written into the Affordable Care Act as “workplace wellness”, the American Obesity Association has ceased to exist.
It has managed to make being fat into a pathological disease, and helped enshrine stigma against fat people into government policy, so it’s ultimate purpose has been fulfilled.
The revolving door
In 1974, the Senate held hearings into allegations that high level FDA officials had retaliated against scientists who blocked the approval of certain drugs. Pondimin (the fen in fen phen) was one of those drugs.
Dr. Robert O Knox had tried to prevent the approval of the drug in the 1970s. The hearings, which were called the Dorsen Commission, suggested that Dr. Knox was the victim of collusion between some of his supervisors at the FDA and the drug company making Pondimin (Wyeth) to remove him from the review process. The drug was signed off on by an FDA division director, Marion Finkle, who went on to become an “expert witness” for drug companies, including Wyeth. (23)
Michael Weintraub was the inventor of fen phen. It was his idea to combine Pondimin with a stimulant to counteract the drowsiness side effect. He received a grant from the National Institutes of Health (NIH)through their research arm, the National Heart, Lung, and Blood Institute (NHLBI) in 1983.
The study ended in 1987, but was not published until 1992. The plaintiff’s lawyers in the fen phen civil suit wondered if the study was published with Wyeth’s help. The study was published as a special supplement to the journal, and supplements are not published for free.
Weintraub said that the NIH paid to have the study published, but the NIH said his funding had run out in 1986. “Later, through his attorney, he said he believed he received funds from “industry” to publish it — but he couldn’t remember how much or from whom.”
Weintraub’s study being published in a major journal was perfect for Wyeth. It is the subject of an article in 1995 in Allure magazine and it reprinted in Reader’s Digest.
“Interestingly, when Weintraub has his NIH grant in the mid 1980s, the National Heart, Lung, and Blood Institute was being run by a young star in drug research, Robert Levy. By the date of Weintraub’s publication in 1992, Wyeth owned the A.H. Robins company, which had supported Weintraub’s work. And Bob Levy was coming on board at Wyeth’s corporate parent, AHP, as director of research.” (23)
In the Allure article, Weintraub stated, in error, that the side effect of pulmonary hypertension went away when fen phen was discontinued. This is a massive mistake or error, as PPH is a fatal disease with no cure.
Weintraub has also started working for the FDA, where he sat in on internal meetings regarding the approval of Redux, even though he was not considered an “obesity” drug expert within the agency. (24)
Weintraub was also accused of promoting fen phen diet clinics while he was still working at the FDA. (25)
Weintraub was included on the panel of experts in 1998 who changed the BMI guidelines. (26).
“At least 7 of the 9 members on the NIH’s Obesity Task force were directors of weight loss clinics and most had multiple financial relationships with private industry.”
While the NIH insisted that they were only bringing national standards in line with the World Health Organization (WHO), in reality, the cutoffs were drafted by the International Obesity Task Force, which receives much of it’s funding from Hoffman-La Roche (makers of the diet drug Xenical) and Abbott Laboratories (makers of the diet drug Meridia).
“Their primary platform is to lobby governments and advance an agenda that is consistent with the platform of the pharmaceutical industry.”
An examination of the boards of the so-called grassroots advocates, like the American Obesity Association, finds that every single board member has some kind of financial tie to the weight loss or pharmaceutical industries. (27)
And this is where we arrive to where we stand today, at the mercy of weight loss and drug companies. The truth is for sale, and the relentless stigmatization of fat people is nothing more than money in corporate pockets.
This was all done deliberately, to sell a drug that maimed and killed people, mostly women. The entire structure of health care was changed to make this parasitic, evil industry more money.
Turning “obesity” into a disease made the government money flow freely, increasing deadly weight loss surgeries. Weight Watchers is now subsidized by the government, thru tax cuts for “workplace wellness”. And all the major weight loss companies are now owned by hedge funds.
It’s pure corruption, all the way down. And not a single person outside of fat activism cares.
(Originally published on ok2befat.com, then on Medium.com on Sep 9, 2016)
