The FDA’s decision to refuse to approve an experimental drug called Medtronic’s drug Medtronx for use in cancer patients was the result of an aggressive lobbying campaign by pharmaceutical companies, the American Cancer Society and the American Medical Association, the organization said Tuesday.
More than 2 million people around the world have been treated for a form of the cancer-causing protein, and more than 30,000 have died, according to a study published in The Lancet last month.
The drug, called C-myc, is being tested in two types of patients, including those with advanced cancer and the recently diagnosed.
It is used to treat patients who have been told they have Stage IV cancer and are in the early stages of the disease, which means they have limited or no treatment options.
Its approval was a big win for patients like Margo Haskins of North Carolina, who was diagnosed with breast cancer and told she would not receive chemotherapy or radiation therapy for several years because of the risks.
She was told by her doctors she would be given a shot of Medtronics Medtranx every three months.
“I’m in so much pain,” she said.
“The pain is so bad that I don’t know how to stop it.
It’s just the most painful thing I have ever experienced.”
Haskins was also told she could not have chemotherapy, even though she has Stage IV, because her cancer cells were so advanced.
She has been taking the drug daily for two years, and has experienced less pain than before.
“I am in complete disbelief,” Haskis said.
A second drug, Gleevec, is in clinical trials and is expected to be approved for use later this year, according for its makers, Biogen Idec.
Its use is not approved for people over age 60.
But the decision by the FDA was met with criticism from the American Society of Clinical Oncology and Cancer, which said it “has no legitimate basis for concluding that patients with advanced-stage cancer should be given the option of chemotherapy and radiation treatment.”
“This action is completely at odds with the evidence-based medical consensus that C-Myc is safe and effective and should be approved,” the group said in a statement.
As the debate over Medtrontan raged on, a growing number of patients were choosing alternative treatments that had little or no evidence of benefit.
Some of them were taking drugs that were not approved, including drugs made by a company called Genentech, which has received approval from the FDA to use Medtroid in patients with Stage IV cancers.
Meanwhile, a study released by the American College of Radiology found that patients treated with a second drug called Genexa, also made by Biogen, were twice as likely to die compared with those who were treated with placebo.
The FDA had denied approval for both drugs in October, saying it could not determine whether the drugs were effective enough to be a safe treatment for patients with lung cancer.
Dr. Anthony Fauci, the chief of the Division of Clinical Trials at the Mayo Clinic, said he was disappointed by the decision.
“We were able to demonstrate a benefit in the treatment of lung cancer with C-MedtronX, and the safety and efficacy of Genexas Medtrazon and Genexab, but we also saw a clear need for additional data to support these claims,” he said.
“This decision is a setback to the patients we care about and the millions of lives we care for every day.”‘
I can’t believe the FDA would give the thumbs down to a drug that’s going to save my life’In a statement, the FDA said it was taking the decision seriously, and was studying the issue.
“[I]f a potential risk to human health exists, it is important to review the application, the drug’s efficacy, the risks and benefits to the public and the potential regulatory implications,” it said.
“The FDA does not approve medications or medical devices based on their safety or effectiveness for use on humans.
We will continue to carefully review all relevant studies and data to determine the best approach to evaluating potential risks and risks to human life and the public.”
The FDA also said it would review the decision “to determine whether we should reconsider or revise the decision” and to determine how to proceed in future cases.
The agency said it is working with the FDA and other agencies on the review.
The agency also said the FDA will continue “to carefully review the applications and other information received.”
Read moreThe FDA said in the statement that it is “considering all available options” and will “continue to work with regulators, including the Department of Health and Human Services and other relevant federal agencies, to ensure that the decision is appropriately supported by sound science.”
The agency’s decision comes as more than a dozen states have passed laws that restrict or ban the use of Med