Monthly Archives: February 2015

Herbal Supplement Industry Under Fire

On February 3, the New York State Attorney General’s Office accused four major retailers of selling fraudulent and potentially dangerous herbal supplements, demanding that they cease the sale of these products. Law enforcement officials investigated herbal supplements sold at GNC, Target, Walgreens and Wal-Mart. The investigation found that four out of five products tested did not contain any of the herbs on their labels. The pills only contained cheap fillers like powdered rice, asparagus, and houseplants. In some cases, the supplements consisted of common allergens, such as wheat-products.

Health experts welcomed the investigation, having long complained about the quality and safety of dietary supplements. The Dietary Supplement Health and Education Act (DSHEA) of 1994 exempts substances from the requirements to demonstrate safety and effectiveness and from the Food and Drug Administration’s (FDA) pre-market approval. In contrast, the European Union regulates dietary supplements and requires a demonstration of safety before they can be sold. On the other hand, the FDA strictly regulates pharmaceuticals. Under 21 U.S.C. § 355, a provision of the Federal Food, Drug, and Cosmetic Act, the FDA requires that new drugs demonstrate safety and effectiveness through scientific evidence before receiving market approval.

In the past, the FDA has issued warning letters to manufacturers of dangerous supplements requiring them to either change the recipe of their supplement or remove their product from the market. In the majority of these cases, the FDA has received several reports of adverse events from consumers. For example, in November 2014, the FDA issued a warning letter to V26 Slimming Coffee because it contained sibutramine, a controlled substance that was removed from the market in October 2010 for safety reasons. Consumers may look at the FDA’s Consumer Updates web site for updates on recalls and alerts. However, this move by the New York State Attorney General’s Office is the first time a law enforcement agency has threatened the biggest retail and drugstore chains with legal action for selling “deliberately misleading herbal products.”

Some of the investigation’s findings at these retailers included:

  1. Walgreens: store brand of ginseng pills contained only powdered garlic and rice;
  2. Walmart: ginkgo biloba contained no ginkgo biloba, but radish, wheat, rice, and mustard;
  3. Target: six herbal products tested negative for the herbs on their labels but did contain powdered rice, beans, peas and wild carrots; and,
  4. GNC: pills contained unlisted ingredients used as fillers like powdered peanuts and soybeans.

Regulating supplements has been hotly debated in Congress. Senator Orrin Hatch (R-UT), the sponsor of DSHEA, has successfully opposed potential amendments that would require supplement makers to register their products with the FDA. In 2013, Senators Richard Blumenthal (D-CT) and Richard Durbin (D-IL) introduced the Dietary Supplement Labeling Act, which would require dietary supplement manufacturers to register their products with the FDA and to disclose known risks of any ingredients on their labels. However, this bill remains in the Committee on Health, Education, Labor, and Pensions (HELP).

Industry representatives dispute the testing methods used in the investigation, arguing that only a handful of fringe companies have caused these problems. However, New York’s investigations targeted store generic brands at national drugstores and retail giants, suggesting that these problems are pervasive and extensive. Dr. Pieter Cohen, an assistant professor at Harvard Medical School and an expert on supplement safety, stated, “If this data is accurate, then it is an unbelievably devastating indictment of the industry.”

Currently, tests are being conducted to confirm the results of New York’s investigation. Until the results are released, the debate continues. Consumers should be wary that the supplements they are taking may not contain the ingredient listed on their labels. James Hamblin, a physician and senior editor at The Atlantic, notes that even if these supplements do not contain their listed ingredients, there may be a legitimate placebo effect to taking these supplements. However, it is better for the public to know what’s in their supplements, rather than letting this “apparent institutionalized fraud” continue. Consumers have a right to know what is in their products, what they are putting in their bodies, and what they are spending their money on. The Dietary Supplement Labeling Act is a commendable step in the right direction, and the Senate HELP Committee should move it forward.


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Warehouse fire highlights importance of EHR

A warehouse fire in the Williamsburg neighborhood of Brooklyn, NY provided yet another compelling argument for the need for protected health information to be accessible through an Electronic Health Record (EHR) system. The federal government, through the Department of Health and Human Services (HHS), among other entities, have released various statements highlighting the importance of developing EHRs. The fire, which burned a Williamsburg warehouse on January 31, 2015, resulted in innumerable pieces of personal health information (PHI) littering the streets of New York. The fire, which began on a Saturday, still burned on Monday.

According to EHR Intelligence, “recovery specialists [continue to] comb the streets and the East River for fragments of papers with personal health information, social security numbers, and bank account details exposed to the public.” Moreover, EHR Intelligence reports that North Shore-Long Island Jewish Health System, New York-Presbyterian Hospital, NYU Langone Medical Center, and Mount Sinai Health System stored records and patient information at the warehouse. Luckily, all the organizations, according to the New York Times, had copies of the patient records within its respective EHR systems.

Fortunately with responsive recovery teams and on the ground personnel the warehouse fire did not result in a massive breach potentially affecting thousands of patients, but it did illustrate the importance of having effective EHR systems and also the need to store patient data in more than one place. Imagine if any of the health care providers storing data at the warehouse did not have an EHR system. Could you imagine mitigating that situation? What would you tell patients? How would HHS deal with the breach?

The Office of the National Coordinator, within HHS, has numerous resources available to providers to help implement an effect EHR system. Moreover, the ONC provides additional information about the importance of EHR systems to improving patient care. Other than helping to reduce potential breaches, EHR systems are so popular because they help further the goal of interoperability. Interoperability is on the national health care agenda and has support from both Congress and the White House. President Obama’s proposed fiscal year 2016 budget allocates $78 million to ONC, which is a $17 million dollar increase since ONC’s inception, to help further the interoperability mission. Having an effective EHR system helps to promote the interoperability message in that, after the initial interoperable framework is laid by the federal government, it will be crucial for providers to be well equipped with systems that can easily interact with one another. EHR systems allow a patient with various providers to receive more coordinated care. Moreover, EHR systems can make it much less burdensome for individual patients to access their personal health records.

While the weekend warehouse fire is a tell tale example of the necessity for electronic record keeping, the federal government is also invested in the electronic systems to help further an even more important goal: increasing the quality and effectiveness of health care services.

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State Politics, Medicaid Expansion, and Public Health

Since the Supreme Court ruled against the Affordable Care Act’s mandatory Medicaid expansion in 2012, twenty-nine states and the District of Columbia have expanded the program to individuals at or below 138% of the Federal Poverty Index (FPI), or approximately $16,000 for an individual per year. Resistance to the expansion has largely come from states with Republican governors and/or legislatures. However, in December, three GOP governors moved to expand Medicaid in their states – Utah, Tennessee, and Texas. Indiana received Federal approval for its Medicaid plan the last week in January. While a big move in support of the President’s signature health care law, the proposals come with drawbacks that may negatively affect the effectiveness of the expansion.

The Utah expansion does not rely on Federal programs to insure its citizens. Adapting the Arkansas expansion plan, the Utah plan allows the State’s citizens to purchase private insurance with Federal funds rather than enrolling in the Federal Medicaid program. Utah’s program will cover nearly 100,000 residents over the next four years. Residents under 100% FPI continue their enrollment in traditional Medicaid while the “expanded” individuals (between 100-138% FPI) receive assistance to purchase private insurance or enroll in an employer-offered plan. The Utah plan touts $15 monthly premiums. However, the plan also poses a $50 penalty for every Emergency Room visit for a non-emergency situation in an effort to bring down health care costs. Notably, this adapted Medicaid expansion had to be approved by the Centers for Medicaid and Medicare Services (CMS).

Tennessee liked the plan behind Utah’s expansion. Medicaid expansion under these terms has been deemed a compromise between Republican and Democratic ideals. Gov. Bill Haslam has specifically stated that his 2015 proposal is not an expansion of the Medicaid program, but the “unveil[ing] of Insure Tennessee.” Early estimates predict that nearly 200,000 Tennesseans will be eligible for State assistance under the proposed expansion. Notably, Tennessean hospitals are largely in favor of the Expansion. The Tennessee Expansion does more than focus solely on making available funds to purchase private insurance, but also shifts bill-payment to an outcome-based method rather than fee-for-service. Representatives in Tennessee on all sides of the Expansion debate support the Governor’s decision to make insurance available through the proposed means. The proposals must still be approved by the Tennessee legislature and CMS.

The biggest potential win for the President’s health law is the state of Texas. Former Governor Rick Perry has been one of the most vociferous opponents of the Medicaid expansion. However, Governor-Elect Greg Abbott addressed the extremely controversial topic with state lawmakers in Houston. Working with CMS to expand Medicare could mean nearly $10 billion in Federal funds for Texas over the coming years. Texas has the most of any state to gain from the Medicaid Expansion. Nearly 950,000 Texans live between 100-138% FPI. The Kaiser Foundation believes these Texans represent approximately twenty-five percent of all Americans living in the “gap.” The Texas legislature has rejected the “traditional” Expansion, but the Governor-Elect’s meetings may indicate an alternative similar to those in Utah and Tennessee, though his office has yet to comment.

The approval of Indiana’s plan may encourage even more states to expand their Medicaid services. The Indiana plans extends coverage to nearly 350,000 low-income individuals and families. The plan requires enrollees to contribute to a health savings account, an effort to keep “personal responsibility” as part of the expansion. However, the plan comes with high penalties for missed payments, including up to six-month exclusions from the program. The plan also increases reimbursement rates, which were cut across the board by the Affordable Care Act. Indiana’s plan has already caught the attention of the Wyoming legislature.

The twenty-two states that are yet to expand the Federal program need to act quickly. The Affordable Care Act only covers 100% of any state’s expansion through 2016, covering only 90% of associated costs thereafter. Understandably, political and ideological differences will hamper Medicaid expansion in many states. However, Utah’s adaptation to the Medicaid expansion may allow well-meaning legislatures to not only follow their ideals but also act in the best interest of their citizens. In Tennessee, for example, the proposal allows the State legislature to provide expanded coverage while encouraging Tennesseans to take an active role and have more personal responsibility for their own health care.

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