Examiner: Cummings and University of Maryland’s Brenda Frese: Team up for good

July 25, 2012
Articles and Columns
Examiner: Cummings and University of Maryland’s Brenda Frese: Team up for good

On Wednesday July 25, at 2:30 pm, in the Russell Senate Office Building in Washington, DC, Rep. Elijah E. Cummings will testify before the Senate Commerce Committee regarding the investigative report on “gray-market” drug companies. The investigation revolves around the purported actions of pharmaceutical companies believed to be creating a false shortage of key life-saving medicines in order to charge exorbitantly high prices. The testimony will be the result of a letter written to Cummings by one of his state’s constituents, Brenda Frese.

When Brenda Frese, Head Coach of the University of Maryland’s women’s basketball program, read in the Washington Post on April 18, 2011 a story entitled “When the drug you need is nowhere to be found,” she was horrified. The story was written by Hagop M. Kantarjian, a doctor who was troubled by life-saving medicines listed on the U.S. Food and Drug Administration (FDA) drug shortage list. He initiated the call for information and found his e-mail in-box flooded with information that led to the Post story.

One of those drugs listed in short supply (since December, 2010) was cytarabine, used for the treatment of acute myeloid leukemia (AML). That drug hit home, hard, for Brenda Frese and her husband, Mark Thomas, today the parents of 4-year-old twin sons, Tyler Joseph and Markus William. Tyler has Pre-B Cell ALL (Acute Lymphoblastic Leukemia).

Thomas said their son Tyler, “received six doses of cytarabine in the first six months of his chemotherapy.” When Tyler needed the drug it was available. How important is it to have access to this single drug? Dr. Kantarjian in his Washington Post story says the following:

    “...Cytarabine was first approved by the FDA in 1969. For four decades, it has been the backbone of AML treatment. With cytarabine combination chemotherapy, the cure rate in AML is 40% to 50%. Without cytarabine, there is no cure.”

A mother’s heart moved Brenda Frese into action. As Frese shared today via e-mail:

    “I became aware of this issue when I was sitting at breakfast one morning in spring of 2011. As I read further into the story my state of disbelief and disgust grew. I'm not really a political person, but when my reaction to this was: I have to do something. Maybe if I lend my voice we can bring some attention to the issue and help families that are crying for help and not being heard. I know how bad it feels to be told a loved one has cancer. I can only imagine how it feels to also be told that there are drugs that can cure it, but we can't get them for you. At that point, what's the difference between our own health care and that of a third world nation? There's no excuse for it here in the United States. It's unacceptable."

When Frese saw that cytarabine was on that list of drugs designated as in short supply, it was the impetus for her to write her first letter, ever, to an elected official. She wrote it fast, and she wrote it from the heart. And she sent it out to all of the elected officials in Maryland in hopes someone would respond. Rep. Elijah Cummings heard her, loud and clear. Frese wrote:

    “From what I understand the shortage (of life-saving drugs) isn’t the result of a lack of natural resources or research dollars, but simply a choice by pharmaceutical companies because their profit margin on the drug isn’t high enough. This is wrong on every level...Time is critical in this matter because lives are hanging in the balance. I urge you to bring the pharmaceutical companies before Congress to expedite a resolution and explain their sorry and shameful business practices. Moreover, they should have to address leukemia patients and their families, who have seen their living hell get worse and have quite literally been issued a death sentence by the pharmaceutical companies.” (See slide show for Frese’s complete letter.)

Cummings represents the 7th Congressional District of Maryland, encompassing parts of Baltimore City, Baltimore County and Howard County. Frese’s letter was the spark that ignited the fire inside Cummings, as he pored deep into volumes of reports, began conversations and started inquiries into the area now called “drug speculation by gray-market drug companies that trade in drugs that are in critically short supply, according to the Food and Drug Administration (FDA). The drugs in question treat life-threatening illnesses such as leukemia in children, breast cancer, and seizures.”

As his first step in response to Frese's letter, Rep. Cummings began his investigation into potential prescription drug price gouging by sending “document request letters to the following five drug companies seeking information about where they are obtaining these drugs and how much they are making in profits: Allied Medical Supply, Inc., Superior Medical Supply, Inc., Premium Health Services, Inc., PRN Pharmaceuticals, and Reliance Wholesale, Inc.” Allied Medical Supply, Inc. is targeted because of their sale of cytarabine, a drug used to treat leukemia in children and adults.

On May 22 this year, Rep. Cummings introduced a bill (H.R.5853) “to protect wholesalers from purchasing prescription drugs from pharmacies, and to enhance information and transparency regarding drug wholesalers engaged in interstate commerce.” The bill was referred to the Committee on Energy and Commerce.

Rep. Cummings released a press statement regarding the bill that same day, one year after receiving his letter from Brenda Frese, noting: “Nobody should be allowed to engage in profiteering at the expense of children and adults with cancer or other critical illnesses by jacking up the price of drugs that are in critically short supply...This bill closes down loopholes in the supply chain and ensures that consumers have more information about who is handling their drugs.”

The elements of the Cummings bill include: (a) prohibition on wholesalers buying drugs from pharmacies (the genesis of hoarding and creating a false shortage to drive up the price); (b) create a national wholesaler database to help identify problems of supply; (c) state regulator information on wholesalers; and, (d) sales price information to buyers of shortage drugs.

The U.S. Food and Drug Administration (FDA) maintains a standard list (available online) of current drug shortages at all times. Their web site shared information provided by manufacturers, and there are instructions on how to report a shortage or supply issue on the site. The FDA notes it “cannot require firms to report the reason for shortage or duration of the shortage or any other information about shortages,” but if reasons are provided by the manufacturers, they’re listed on the FDA’s site.

Three companies are noted by Dr. Kantarjian as U.S. manufacturers of cytarabine: “Bedford Laboratories, Hospira and APP Pharmaceuticals.” And cytarabine was just one of the medicines on that shortage list. Another is methotrexate, another key ingredient to Tyler Thomas’ chemotherapy path.

Today, the Bedford web site shows an update that’s four months old, from February 15, 2012: “To answer the urgent need for Bedford Laboratories’ methotrexate, Ben Venue Laboratories has been actively working with the U.S. FDA to expedite the availability of preservative-free methotrexate for injection USP.” Their latest news item prior to that was dated December 23, 2011, which makes the case for additional up-to-date accurate and specific information abundantly clear.

As the web site for the Committee on Oversight and Government Reform compares the prices of key chemotherapy medicines in normal circumstances vs. shortage prices:

    “Typical contract price for cytarabine is about $12 per vial. Allied Medical Supply’s price is over $990 per vial;

    Typical contract price for paclitaxel (used as treatment in breast and ovarian cancer) is about $65 per vial. Superior Medical Supply is cited as charging over $500 per vial;

    Typical contract price for leucovonin (used to treat advanced colon cancer) is about $5 per vial; Premium Health Services, Inc. charged over $270 per vial;

    Magnesium sulfate (used to treat life-threatening seizures in pregnant women) is about $9 for 25 vials on a typical contract price; Reliance Wholesale, Inc. set a price of over $400 for 25 vials;

    Fluorouracil (used to treat colon, stomach, breast and pancreatic cancer) is about $15 per vial on a typical contract price; PRN Pharmaceuticals price was over $350 per vial.”

Frese’s husband, Mark Thomas said, “She sent her letter to every Congressional representative in Maryland, expressing our dismay over what we see as criminally tragic corruption.” The result of that letter can be seen on the web site for the U.S. Congressional Committee on Oversight and Government Reform, of which Rep. Cummings is the ranking member.

The role of higher education in contributing to the life of any community, city and state extends far beyond the walls of classrooms nestled safely inside ivy-covered buildings, or any basketball field houses, to be sure. At least Brenda Frese feels that way. On the Maryland Women’s Basketball’s web site it says:

    “Our fun, family environment allows every student-athlete to always feel at home here at Maryland. We travel all over the US and the world, providing our student-athletes with new and exciting cultural experiences. Our nationally ranked academic programs prepare our student-athletes for a successful life after Maryland. Our involvement in the community helps shape our student-athletes, teaching life lessons. All of these exciting and new experiences along with our competitive “big-time” basketball environment, ensures that all of our student-athletes become champions for life!”

Brenda Frese runs her University of Maryland’s women’s basketball program based on her beliefs in “the two P's”: patience and positivity. Frese teaches what she preaches, gives as she lives, and continues to be one of the most sterling examples of university faculty members, athletic coaches and role models for young women about making a difference in the world. Life is indeed “more than just basketball” at the University of Maryland. As the lyrics to a 1969 Kurt Kaiser praise song, “Pass it On” go: “It only takes a spark to get a fire going.” Brenda Frese was the spark; Rep. Cummings took that spark, turned it into a flame and is now holding the virtual “feet” of the gray-market drug companies to that fire.

It took only slightly more than a year, but Wednesday’s bicameral meeting will be the first step in revealing the results of that investigation. In a day and time when people ask the rhetorical question, “what good will it do to write or call my elected officials?” the answer, thanks to Rep. Cummings is clear.

The bicameral investigation anchored by Cummings has been jointly led, since December 15, 2011, by Senator John D. Rockefeller, IV, of West Virginia, Chairman of the Senate Commerce Committee and Senator Tom Harkin, Chairman of the Senate Health, Education, Labor, and Pensions Committee.

Edmund Burke said it best: “All that is needed for evil to triumph is for good men to do nothing.” Fortunately for all, Brenda Frese did something. Elected officials listened to her words, saw her heart, and now the secrets kept for so long about key drug shortages and the existence of “gray markets” have come to light—at last.

The future health of today’s children depends heavily on actions taken by the U.S. Senate Commerce Committee. Senator Tom Harkin of Iowa, who co-leads the reform initiative, also indirectly represents Brenda Frese, as she is an Iowa native. Harkin is a busy man as well, as regards higher education issues.

As a side note, Sen. Harkin’s web site notes, “As Chairman of the HELP Committee, Senator Harkin has conducted an in-depth investigation into for-profit higher education companies over the past two years, uncovering deceptive marketing practices, huge profits, poor student outcomes, and questionable investment of taxpayer-funded education benefits.” Vigilence everywhere is vital, to be sure, now more than ever.

Those gray-market drug companies have some detailed explanations ahead of them, fortunately for consumers. The accompanying video (inset) from CBS News reporter, Scott Pelley, provides additional insight into the actions of gray-market drug companies.

Wednesday’s hearing will be webcast live on the Senate Commerce Committee site. Unfortunately, Coach Frese could not accept Rep. Cummings’ invitation to attend the hearing because she is on a recruiting visit to enhance the future of Maryland Terrapins women’s basketball (2006 NCAA National Champions). Her husband, Mark Thomas, can’t attend in her behalf, either.

Said Thomas today, “Tomorrow is Tyler’s monthly visit to the clinic at Johns Hopkins to get a checkup and medicines administered through the port in his chest; coincidence that it’s the same day as this hearing. While Tyler will get life-saving chemo pumped through his body, Congress will be addressing the practices of pharmaceutical companies that have led to life-threatening shortages.”

Whether or not you live in Maryland, there is still time for voices to be raised and voters to share their thoughts with elected officials on this key topic. One letter can make a difference. There are children counting on elected officials to protect and safeguard their access to life-saving medicines. It is, truly, a matter of life and death.