FDA: Dump the GSK Supplement-Killer Petition!
Posted Wednesday, May 21, 2008

by James J. Gormley 

On April 17th, 2008, pharmaceutical giant GlaxoSmithKline (GSK) submitted a Citizen Petition (FDA-2008-P-0248-0001) calling for the U.S. Food and Drug Administration (FDA) to reclassify all weight loss support claims for dietary supplements as disease claims.

GSK was joined in this petition by three organizations that it supports: the American Dietetic Association, The Obesity Society and Shaping America’s Health. The organizations’ signatories included a lobbyist, a person who helped get obesity classified as a disease and a fundraising guru.

If the FDA were to—in a hypothetical act of audacious ignorance—agree with this petition, American consumers would be unarguably cheated out of hundreds of legally and responsibly marketed dietary supplement products.

The stage would be set for challenges to other types of claims and to what would constitute irreparable damage to the dietary supplement industry and irrevocable losses to consumer choice.

What a shameful state of affairs this is for the FDA.

Citizen petitions, when originally instituted, were supposed to be just that: a formal means for a citizen, or more broadly the public, to contact the FDA and “seek its action or response on a particular matter.”

The original intent of citizen petitions has been perverted to now facilitate “citizen” petitions from corporate behemoths that are so removed from anything remotely resembling a citizen, or the public at large, that to continue calling them “citizen petitions” is an insult to Americans.

Perhaps they should be called “Big Pharma Petitions” since the ones submitted by actual citizens, citizens groups and the public are the ones which tend to fall into the eternal and stygian FDA backlog—unless, of course, the petition challenges the sacred cow of FDA decision making.

Such a sacred cow was challenged by the non-profit group, Public Citizen (a true consumer group), on April 10th, 2006, when it called on the Agency to not allow a GSK drug (orlistat)—which is said by the group to have a history of side effects and gastrointestinal problems—to be re-classified as an over-the-counter (OTC) weight loss drug, now called alli™.

Public Citizen’s objections cited such embarrassing product usage problems as anal leakage and such serious problems as pre-cancerous lesions.

On February 7th, 2007, the FDA dismissed the group’s well argued petition, saying that the product label already warns people about the messy bowel problems.

As to those pesky pre-cancerous cellular changes allegedly caused by the drug (called “aberrant crypt foci”), the FDA said they aren’t of clinical significance.

Interesting, because according to the NIH National Cancer Institute, aberrant crypt foci represent “one of the earliest changes that can be seen in the colon that may lead to cancer.”

But, then again, FDA’s approvals were being called into question—institutional arrogance can’t allow that—and a powerful drug maker’s products were also being questioned.

Now, let’s turn back to the GSK Citizen Petition.

In the petition’s summary, GSK and its co-petitioners state: “Moreover, the actions requested in this petition would help address concerns about the safety of weight loss supplements” and “By requiring weight-loss supplements to undergo pre-market review, FDA would shift the burden to manufacturers to show that their products are safe.”

What about the potential safety problems related to GSK’s alli™? This product went through both a prescription drug and an albeit cursory OTC safety review process and it still has a number of reported concerns associated with it.

Or what about GSK’s prescription diabetes drug, Avandia? The FDA issued a safety alert related to this drug, indicating that “there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.”

Shortly thereafter the FDA required a “black box warning” with this drug, one which says: “Warning: Congestive Heart Failure and Myocardial Ischemia.” It appears the much-touted FDA drug prescription safety review process didn’t work here either.

Given the solid safety record of dietary supplements sold in health-food stores—and the incredibly poor safety record of drugs foisted on the American public—how could any pharmaceutical company have the unmitigated gall to ask this country (and its servant, the FDA) to ignore the 100,000 deaths and over 1 million adverse events every year from properly prescribed FDA pre-approved drugs?

Could it be because effectively removing dietary supplements that assist people in achieving body composition and weight loss goals would provide Big Pharma an El Dorado, like the legendary lost city of gold?

So I guess the questions are these: 

  1. Are we willing to see irreparable harm come to health food supplements?
  2. Do we want Big Pharma to manipulate the tools of public redress to do this?
  3. Do we want to offer the drug makers with an incalculable revenue boon while delivering a mortal wound to the natural products industry?
  4. Do we want Big Pharma and the FDA to decide what sorts of products we can have access to?
  5. Or do we want to keep our dearly won health freedoms? 

If your answer is “No!” to the first four questions and “Yes!” to the very last question, then please comment below with exactly what you think about this so-called Citizen Petition.

If you want them, as I do, to summarily deny this outrageous petition, then please indicate that in your comment below.

An award-winning journalist, published author, and member of the prestigious American Society of Journalists and Authors (ASJA), Gormley has 20 years of experience in health-related media communications. He is a senior policy advisor for Citizens for Health (www.citizens.org), an advisory board member of the National Health Research Institute (NHRI)and a member of the Institute of Food Technologists (IFT). From 2006 to 2008, Gormley directed three leading health-food trade magazines for VRM Inc. He is perhaps best known for having served as the longtime editor-in-chief of Better Nutrition magazine (1995 to 2002) and for having founded Remedies magazine in 2006. A consumer health advocate and industry champion, Gormley has also been a frequent guest on television and national radio where he has spoken out on a variety of health and regulatory issues.

guest on July 22, 2008 at 10:58:25 pm

Dear Terrie,Well said!James
guest on July 22, 2008 at 12:37:10 pm

First we give them ritalin then statin drugs. What next--Prozac? Soon we will have a nation of automatons.
guest on May 29, 2008 at 10:54:20 am

Dear Laura, I do agree that we need to strongly stand up for our rights and to protect a class of healthful products that we value. The FDA, when it works properly and in many areas, serves a valuable public good.....even pharma companies do provide certain life-saving medications, such as GSK's AIDS medications, Trizivir and Combivir. I don't object to their right to exist. I object to a profit-driven presumption that our health-food products do not have a right to exist and the misuse of tools of public redress in order to accomplish this. Many thanks. James
guest on May 27, 2008 at 9:05:01 am

We need to start getting more aggressive with these pharmaceutical companies AND these Federal agencies who think they OWN us, "A government by the people and for the people"... land for the free my a**!! They need to be stopped to the point of non-existing.
guest on May 22, 2008 at 7:57:29 pm

Dear Jacqui,Right on. It is so paternalistic, and somehow Orwellian, for a government (and the power brokers) to say to us that we do not know enough to make our own informed decisions so those decisions will be made for us via censorship of claims and consequent loss of a legitimate class of products.Best,James
guest on May 22, 2008 at 7:17:54 pm

As if this is about health at all. It's about the benjamins. And big pharma are the ones that need to be stopped. I do believe it is thier drugs, whether mis-prescribed or mis-used, that are the leading cause of death in this country not diet pills. They want to monopolize an industry so they can keep paying themselves multi-milloin dollar bonuses. Outrageous.
guest on May 22, 2008 at 5:15:13 pm

Consumers need to be responsible for their own health regardless if it's an OTC medication or food supplement. I saw over three specialists concerning a hive problem induced by stress and no one could help me. I took matters into my own hands and looked into homeopathy and can you believe that a $10 bottle of L-Lysine cured my ails? The Horror that I could actually find relief without a prescription! Responsibility is now being taken away along with choice...people need to have choices in how they take care of themselves. Its as if this country is trying to protect us from ourselves! Are we really free?
guest on May 22, 2008 at 4:56:08 pm

Keep the governement and pharma companies out of the industry. They are in bed together only to make money and hurt the small business owner.
guest on May 22, 2008 at 4:21:57 pm

Dear All,Thanks for your support and your courage. And, Trisha, I would like to briefly respond to your comment if I could. Pre-market approval is not a guarantee of safety as witnessed by those drug products that have been approved by FDA, only to be later recalled due to safety concerns. Like food products, dietary supplements do not undergo pre-market approval, but that does not mean that companies don't do testing, or that products are unsafe. There are provisions under DSHEA that help protect consumers from potentially unsafe products. Further, DSHEA provided FDA with additional enforcement authority, including the ability to remove from the market products the agency deems unsafe through: 1) an "imminent hazard" clause which permits FDA to immediately remove a product it considers to present an immediate safety concern and 2) a "significant or unreasonable risk" clause that allows removal of a product considered to pose an unacceptable risk of illness or injury. But the overwhelming majority of dietary supplements are safely used by 150 million Americans annually. Safe weight loss practices are important for everyone, whether these practices include OTC drugs, prescription drugs, exercise and diet (including food supplements). Supplement sare often blamed as "interfering with drug effects" when drugs are to blame for depleting vitamins and minerals and for blocking or interfering with the body's natural metabolic processes, such as breakdown of fats. I would be much more concerned as to interaction among drugs and side effects on the body than about whether a food supplement is the culprit. IN many case, irresponsible use of whatever product or substance is to blame, regardless of what bioactive product (drug or natural substance). The dietary supplement industry had to force the government to finally pass the AER law and to promulgate the GMPs--the government had dragged its feet for years, not the supplement industry. Not allowing supplement manufacturers to provide meaningful information to consumers about the products they purchase is not being responsible; it's censorship, and it is the consumer who will suffer by not having access to that important information. My idea of protecting consumers is to arm them with more information, not less, with which to make informed purchasing decisions. Surely we do not want a dystopian state in which the FDA and drug makers decide what information people should have and should not have available.
guest on May 22, 2008 at 2:19:45 pm

Too bad we have to continually fight for freedom against big organizations with MONEY. If anyone thinks this isn't about money they need to get educated on the subject.
guest on May 22, 2008 at 1:44:34 pm

The richest looby in the federal government strikes again. The idea that proper nutrition and dietary supplements are dangerous is the most rediculous notion imaginable. All this is is an attempt to make more money by the big pharmaceutical companies. Shameful!!
guest on May 22, 2008 at 8:36:45 am

I think this is GOOD. Most weight loss supplements have not been tested to prove they work or are safe and many are NOT safe. As an army dietitian I have to constantly educate soldiers on SAFE weight loss practices. In addition, some of the ingredients in these supplements have different effects in a deployment setting under stress, with other medications, or with other comorbidies. Most soldiers (and other consumers) don't know what the ingredients are and if they interact with prescribed medications. There are 30,000 supplements available...$18 billion dollar industry. I don't think they are going to suffer by being more responsible with their products.
guest on May 22, 2008 at 7:47:32 am

Again they are trying to take away another of our God given freedoms.This only shows the infinite stupidity of our government.
guest on May 22, 2008 at 7:20:12 am

I deny this outrageous petition,it has to stop.
guest on May 22, 2008 at 2:48:29 am

Big pharms have been robing us for years, now they want to rape us!!
guest on May 22, 2008 at 12:40:20 am

This is just another thinly veiled attempt by the pharma. industry to continue to chisle away at the present "Freedom of Choice" we now enjoy when choosing a natural or nutrition based approach to address our health, for preventative or causative reasons. The fact that the FDA will take seriously such a self-interested and selfish complaint is not surprising given their attitude of late. There is much too much evidence that the present drug approval process is very flawed and has allowed numerous unnecessary deaths to the unsuspecting public. I would hope the FDA would get it's proverbial house in order and fix their present approval system before turning their attention to the supplement and vitamin industry. Our health will stand a much better chance of "survivng" the FDA if they would simply stick to what they appear to know least, that is, keeping the public safe from dangerous pharmaceuticals.

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