FDA Commissioner Margaret Hamburg Stepping Down

Dr. Margaret Hamburg, the commissioner of the Food and Drug Administration (FDA), announced that she would be stepping down as commissioner at the end of March 2015.

As one of the longest-serving commissioners at the agency, Hamburg led the FDA for close to six years. She said the heavy demands of the job as well as the length of time she’s been serving contributed to her decision to resign.

While some have praised Hamburg’s time at the FDA, others, like Dr. Michael Carome, the director of the health research group at Public Citizen, have been more critical, calling her tenure a period of “weak and ineffective leadership.” He said in a statement:¹

“Too often, the F.D.A. has succumbed to industry and political pressures, implementing policies and taking actions that tilt too far toward the bottom-line interests of pharmaceutical and medical-device companies, and away from protecting public health… Throughout Hamburg's tenure, the FDA has grown even more cozy with the industries that it regulates.”

Strong Ties to Industry from the Very Beginning…

Hamburg entered the FDA through the revolving government/private industry door after allegedly making millions as the director of Henry Schein Inc., the largest seller of dental amalgam (mercury fillings) and flu vaccine seller as well.² To get appointed, Hamburg was required to sign an agreement promising:

1. To sell her Schein stock and stock options
2. Not to participate in regulatory matters affecting Schein while owning these options

Sign she did, but she apparently had her fingers crossed. Selling her stock, Hamburg retained her stock options, which in a few weeks gained from being "under water" (no value) to having market value. Promising to cut her ties with Schein, she allegedly continued regular correspondence with Schein's general counsel on her private e-mail.

Hamburg took office as Commissioner in May 2009. Charlie Brown, director of Consumers for Dental Choice, wrote her June 1, 2009 to inquire whether she had recused (disqualified) herself from working on an upcoming amalgam rule.

Not even answering, she convened a meeting with the American Dental Association's “best friend” at the FDA, dentist Susan Runner. On July 1, in a meeting whose notes are heavily expunged from public records requests, Henry Schein alumna Hamburg and pro-amalgam dentist Runner put together a disgraceful rule on amalgam.

It allowed continued concealment of the mercury within, buried the warnings for children and unborn children so deep in the rule no one would find them, and allowed Runner to be the FDA's spokesperson to proclaim amalgam safe.

At the end of July, Runner unveiled this monstrosity of a rule and, immediately after Runner's announcement, Schein's general counsel wrote Hamburg that Schein is "indebted" to her for her work as Commissioner. Hamburg was still holding Schein stock options until July 27, the day before the FDA rule was announced.

The FDA agreed that Margaret Hamburg had an ethical problem that led to her recusal, but neither she nor anyone else at the FDA would say what work she did on the rule or when she stopped working on it.

Under Hamburg, the FDA Continues to Allow Antibiotic-Resistant Disease to Flourish

The FDA has long been accused of ignoring the elephant in the room when it comes to antibiotic-resistant disease, namely factory farming practices where antibiotics are routinely fed to animals to promote growth.

According to the landmark “Antibiotic Resistance Threat Report” published by the CDC in October 2013, 2 million American adults and children become infected with antibiotic-resistant bacteria each year, and at least 23,000 of them die as a direct result of those infections.³ Even more die from complications.

As noted in Rodale Magazine, the FDA knows the dangers of antibiotics in animal feed, but continues to allow them, thereby allowing the problem to persist and grow unchecked:⁴

“The Food and Drug Administration (FDA) has known for more than a dozen years that use of antibiotics in factory farms is harmful to humans, yet the agency has taken no meaningful action to stem their use.

That's the conclusion of a new report from the Natural Resources Defense Council (NRDC), published after the environmental nonprofit collected data from the agency through a Freedom of Information Act request.⁵

The data came from an internal review on the safety of feed additives belonging to penicillin and tetracycline classes of antibiotics. The review started in 2001 and ended—for unknown reasons—in 2010. The findings: Twenty-six of the 30 drugs reviewed didn't meet safety guidelines set in 1973, and none of those drugs would meet the safety guidelines of today.”

Yet, despite the growing number of people dying from antibiotic-resistant diseases, when the FDA issued its pathetic guidance on agricultural antibiotics in December 2013, they failed miserably at protecting public health.

The agency only went so far as to ask drug companies to voluntarily restrict the use of antibiotics that are important in human medicine by excluding growth promotion in animals as a listed use on the drug label.

This would prevent farmers from legally using antibiotics such as tetracyclines, penicillins, and azithromycin for growth promotion purposes. But this guidance is not likely to protect your health at all, and was exactly what the drug companies were hoping for.

The industry is fond of pointing out the lack of proof directly connecting the antibiotics used in livestock to human disease outbreaks. This is by careful design to deceive you. The industry is not required to collect or report usage data. And without data on how and when drugs are used, such direct connections are very difficult to prove.

When asked why we don’t we have information on antibiotic usage in livestock after more than four decades of use, Hamburg’s beyond lame excuse was that they’re still trying to figure out what kind of data is needed...

In a Frontline News documentary, she also noted that the FDA believes this voluntary approach is going to be the most effective and speedy way to eliminate antibiotics for growth promotion purposes.⁶

The meat industries have agreed to reduce usage, but if no data is collected to verify which drugs are being reduced, and by how much, how can the FDA possibly ascertain the effectiveness of their approach?

So far, promptings to reduce usage appears to have fallen on deaf ears. According to the most recent FDA report, antibiotic usage actually INCREASED by 16 percent between 2009 and 2012, and nearly 70 percent of the antibiotics used are considered “medically important” for humans…⁷ And remember, for each year we delay affirmative action, tens of thousands of Americans die, and the resistance problem keeps growing.

Industry Is Still Adding Dangerous Synthetic Trans Fats to Your Food

According to CDC director Thomas Frieden, an estimated 5,000 Americans die from heart disease caused by synthetic dietary trans fats each year, and another 15,000 will get heart disease as a result of eating too many trans fats.⁸ Other CDC statistics suggest that as many as 20,000 heart attacks could be avoided each year by eliminating trans fats from the food supply.⁹

Trans fat intake has steadily decreased over the past several years, According to FDA estimates, Americans consumed an average of one gram of trans fat per day in 2012, compared to 4.6 grams per day in 2003. However, according to the Institute of Medicine, trans fat is unsafe at any level.

Reuters praised Hamburg for proposing “measures to improve nutrition by limiting dangerous trans-fats in food,”¹⁰ but they are still allowed in your food, even after a lawsuit.In 2009, Dr. Fred Kummerow, who has studied heart disease for more than 60 years, filed a citizen petition with the FDA calling for a ban on synthetic trans fats.¹¹ In the petition, he noted that heart disease is often the result of trans fat deposited in veins and arteries, which can cause sudden death due to blockage.

The FDA is required to respond to such petitions within 180 days, but Dr. Kummerow had yet to receive a final response even four years later. So in 2013, he filed a lawsuit against the FDA, which alleged that the agency’s failure to ban partially hydrogenated oils (which contain synthetic trans fats) along with their unreasonable delay in responding to his 2009 petition, violate the Administrative Procedure Act and the Food, Drug, and Cosmetic Act.

The Food, Drug, and Cosmetic Act prohibits the sale of foods containing poisonous or deleterious substances, and an extensive body of research has linked synthetic trans fats to heart disease, diabetes, cancer, Alzheimer’s disease, and even violent behavior. In November 2013, shortly after the lawsuit was filed, the FDA announced it would now consider removing partially hydrogenated oils—the primary source of trans fats—from the list of "generally recognized as safe" (GRAS) ingredients. They were supposed to accept comments for 60 days, after which a permanent decision would be made. The comment period was up in January 2014… but it was extended.

As you might expect, many of the comments against FDA’s proposal to revoke GRAS status come from the food industry, including ConAgra Foods, Nestle, and a 104-page tome of a comment from the Grocery Manufacturers Association.¹² If finalized, the FDA's decision means that food manufacturers can no longer use partially hydrogenated oils, i.e. trans fats, in their products without jumping through hoops to get special approval. But there still has been no final decision made.¹³ After the lawsuit, the FDA had little choice but to do what it should have done years ago, which is address a well-known toxin in the food supply. It's just too bad that they had to be sued in order to do their job… and still haven’t officially removed it from the GRAS list.

51 New Drug Approvals in 2014… Including Conflict-of-Interest Driven Zohydro

Under Hamburg, the FDA approved 51 new drugs in 2014 alone, which is the most in close to 20 years.¹⁴ In a blog post, Hamburg called the drug approvals “innovative approaches to help expedite development and review of medical products that target unmet medical needs.”¹⁵ But many believe the speedy drug approvals come at the expense of safety. A prime example is the narcotic painkiller Zohydro. Dr. Sanjay Gupta discussed conflicts of interests that may have coaxed the FDA to approve Zohydro ER (Zogenix) last year.¹⁶

The drug, which is the first drug containing pure hydrocodone (synthetic heroin), was approved at the same time that the FDA was also recommending tighter controls on narcotic painkillers, in light of alarming addiction rates and deaths linked to accidental overdoses. All other hydrocodone-containing painkillers on the market are mixed with other non-addictive ingredients. Zohydro ER was approved for patients who need around-the-clock pain relief, and contains an opioid dose that is five to 10 times greater than anything else on the market.

As noted by Dr. Gupta, when FDA Commissioner Margaret Hamburg was criticized for the agency’s approval of Zohydro, she countered saying that “100 million Americans” suffer from severe chronic pain warranting use of the drug. This figure amounts to about 40 percent of the US adult population! Pharmaceutical companies, including the maker of Zohydro, paid up to $35,000 to attend private meetings with the FDA and National Institutes of Health (NIH) staff, in which discussions revolved around the development of new pain treatments. This prompted two US Senators to launch an investigation into what appears to be a classic “pay to play” scheme. According to a MedPageToday report:¹⁷

“[T]he meetings also involved discussions of ‘enriched enrollment’ for pain trials, which enables drug companies to weed out nonresponders or patients who have adverse reactions to the drug from enrollment in clinical trials -- which critics say stacks the deck in favor of the drug... Zohydro clinical trials used the enriched enrollment methodology. During its FDA advisory committee hearing, several experts expressed concerns about what would happen once the drug moved from trials into the real world because of that methodology.”

Three Strikes and You’re Out… Who’s Up Next?

Mercury fillings, antibiotics overuse, trans fats… we have three-plus strikes against Hamburg. She’s out now… anyone want to bet where she’s headed? Back to Henry Schein perhaps? As for who will replace Hamburg, Dr. Robert Califf, a cardiologist and researcher from Duke University who currently oversees the FDA’s drug, medical device and tobacco policy has been fingered as the most likely successor.¹⁸ I’d like to say that he will be a breath of fresh air for the FDA… but Dr. Califf has an extensive list of industry associations of his own to disclose. According to author disclosures listed in the Journal of the American College of Cardiology:¹⁹

“For the period from 2010 through 2013, Dr. Califf reports receiving research grants that partially support his salary from Amylin, Johnson & Johnson, Scios, Merck/Schering-Plough, Schering-Plough Research Institute, Novartis Pharma, Bristol-Myers Squibb Foundation, Aterovax, Bayer, Roche, Lilly, and Schering-Plough; all grants are paid to Duke University.

Dr. Califf also consults for TheHeart.org, Johnson & Johnson, Scios, Kowa Research Institute, Nile, Parkview, Orexigen Therapeutics, Pozen, WebMD, Bristol-Myers Squibb Foundation, AstraZeneca, Bayer-OrthoMcNeil, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, GlaxoSmithKline, Li Ka Shing Knowledge Institute, Medtronic, Merck, Novartis, Sanofi-Aventis, XOMA, University of Florida, Pfizer, Roche, Servier International, DSI-Lilly, Janssen R&D, CV Sight, Regeneron, and Gambro; all income from these consultancies is donated to nonprofit organizations, with most going to the clinical research fellowship fund of the Duke Clinical Research Institute. Dr. Califf holds equity in Nitrox LLC, N30 Pharma, and Portola.”

It’s unlikely that this change in leadership is going to reform the FDA or lead to significant changes in favor of your health. Virtually every measurable index indicates that despite the ever-increasing amounts of money invested, if you live in the US your chance of achieving optimal health through the conventional medical system is getting progressively worse. As just one example, while the US spends more than twice the amount on health care as other developed nations, we rank 49th in life expectancy worldwide—far lower than most other developed nations...The time is ripe for you to take control of your health, and my site is chock full of free comprehensive recommendations that can serve as an excellent, truly independent starting point.

Whatever your health problem or health goal might be, I strongly recommend digging below the surface using all the resources available to you, including your own commonsense and reason, true independent experts' advice, and others' experiences to determine what medical treatment or advice will be best for you. Ultimately, you are responsible for your and your family's health -- not me, not your physician, and certainly not any researchers or government health agencies. I cannot stress enough how important it is to become an active participant in your own care, and make sure you are making decisions that correspond with your own best judgment, knowledge, and experiences.

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