First it was Dr. William Kincaid of the McLeod Cancer and Blood Center in Johnson City. Now, the Food and Drug Administration is investigating a second area doctor for buying unapproved cancer drugs from a foreign distributor.
McLeod Cancer and Blood Center has continued to say it would never purchase or administer any medication it believed would not be effective in the treatment of its patients.
Now, the attorney for Dr. A.K. Sen of East Tennessee Cancer and Blood Center located in Greeneville and Johnson City is echoing those words.
Dr. Sen is one of nearly 140 doctors nationwide linked to an investigation by the FDA into the sale of unapproved cancer drugs from foreign distributors. All of those doctors received letters from the FDA.
The FDA sent a letter to Dr. Sen at the end of June, requesting he stop using all products purchased from foreign distributors. He was one of only four doctors in Tennessee to receive the letter. Dr. Kincaid was another.
"The U.S. Food and Drug Administration has received information indicating that your medical practice purchased multiple medications from a foreign distributor named Clinical Care, Quality Specialty Products, Montana Healthcare Solutions, or Bridgewater Medical," the letter said. "Most, if not all, of the products sold and distributed by this distributor have not been approved by the FDA and may include counterfeit versions of Avastin or Altuzan. The manufacture and handling of these products may not be of suitable quality to ensure safety or efficacy, and the products have not been proven to be safe and effective pursuant to FDA standards. The Agency is very concerned that products distributed by this distributor may cause harm to patients, because they may be unsafe or ineffective."
According to Dr. Sen's attorney, the doctor first became aware he bought unapproved drugs when a FDA agent visited his clinic several months ago. Since then, Ed Yarbrough of Walker, Tipps, & Malone in Nashville said the doctor has cooperated fully with the investigation.
"We've provided (federal authorities) with all of the documents they requested more than a month ago," Yarbrough said. "We are also in touch with the U.S. Attorney's Office in Greeneville and providing them with all the documents they have requested. To our knowledge, no medications of any kind that were prescribed for Dr. Sen's office are in any way detrimental to patients. As far as we are aware at this moment, they were all completely appropriate from the standpoint of their content. Even though they may still be good medicine in terms of the chemical content, we were informed that some of them have not been FDA approved, which came as a surprise to the doctor in his practice and all of those items have been discontinued."
According to Yarbrough, the medications in question were purchased between the years of 2007 and 2011 and used for two-and-a-half to three years during that time.
"When we learned there was concern about whether they had been FDA approved, we checked that, discovered that some did not have the appropriate number or stamp and we discontinued the use of those immediately," Yarbrough continued. "There has been no information that would suggest that any of the drugs were counterfeit or improper in any way. We've had no patient complaints and no bad outcomes that I'm aware of."
Although Dr. Sen is cooperating with the federal investigation, his attorney says no allegations have been made against the doctor.
"The labels and the inserts describing the medication were the same as what they had been using and they were assured by the distributor that it was appropriate for use in the United States," Yarbrough said. "It was not until the agent came and inspected some of those that the office discovered that some of that may not have been officially FDA approved. I just would hope that no one would be alarmed by this news report, because I think the situation has been appropriately addressed by the federal agencies and we are cooperating, and as I say, we have no reason to believe that anyone has been harmed at all by any of these medicines."
According to FDA Public Affairs Specialist Sarah Clark-Lynn, medical practices that have purchased medication from a foreign supplier are "putting patients at risk of exposure to drugs that may be counterfeit, contaminated, improperly stored and transported, ineffective, and dangerous."
In recent months as part of the agency's ongoing investigation, Clark-Lynn says the FDA has learned about additional medical practices that have purchased unapproved drugs from foreign suppliers.
"The FDA is notifying these doctors individually and recommending that they not administer any products obtained from Clinical Care, Quality Specialty Products (QSP), Montana Health Care Solutions, Bridgewater Medical or any other suspect sources to minimize the risks to patients," Clark-Lynn said. "Although FDA has confirmed that counterfeit products were sold to and purchased by doctors in the United States, at this time, the FDA has not identified particular patients known to have received a counterfeit version of Altuzan or Avastin. If a health care provider thinks they have administered or if a patient thinks they have received the counterfeit version of Altuzan or Avastin, they should report that, as well as any adverse events to FDA."
According to the FDA, adverse events that may be related to the use of medications can be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
For information visit www.fda.gov/MedWatch/report.htm