March 2016 Updates

March 2016 Updates

The Quinolone Vigilance Foundation would like to share a few updates.

We received an update on Friday from one of the attorneys representing clients involved in the peripheral neuropathy cases. As you may know, the cases have been consolidated in Minnesota under a Multidistrict Litigation (MDL) with Chief Judge John Tunheim appointed to hear the cases. The MDL allows for cases to proceed much faster through consolidation in one court and through sharing of information. 

 

So far, there have been two status conferences in 2016 regarding the cases. They are held once a month. Status conferences are pre-trial meetings of attorneys before the judge to inform the court how the case is proceeding, what discovery has been conducted such as depositions, production of documents, etc. The next status conference is on March 15. 

 

The Avelox eye injury cases are going to trial in the fall of 2016. 

 

The FDA decision about the generic rule is still delayed. At last check, a decision is scheduled for July 2016 after being delayed twice. QVF continues to put pressure on the FDA to stop delaying the decision and allow generic drug makers to be held to the same standards of brand name drug makers.

 

We also brought in another national law firm whom are handling peripheral neuropathy cases. Information about that will be posted soon. We have confirmed that the attorneys are in good standing with the American Bar Association and we interviewed them extensively, per QVF policy. As always, we receive no funding or compensation of any kind from law firms. We provide information and updates strictly as a resource for patients. 

 

QVF also brought in new research. We are not naming the researchers or the university at this time to protect the integrity of the project. We have confirmed that the researcher does not, and will not, take pharmaceutical money to conduct the research. QVF's policy is that we do not work with researchers who have ties to the pharmaceutical industry. We will only say that the research is an avenue that has not yet been explored. 

 

We met with the Centers for Disease Control and Prevention March 8th after receiving security clearances. The meeting went exceedingly well and we did not need to waste any time convincing CDC representatives that fluoroquinolone toxicity is a real issue and that it is damaging and killing patients. The focus of the meeting was about solutions rather than explaining the problem. The CDC is aware that the FDA is failing patients, that Medwatch is a flawed system, and post market surveillance is non-existent. The CDC is data and evidence-driven. There is also a new reporting system in development because the Medwatch system is not reliable or accurate.

 

QVF is providing data to the CDC and assisting the CDC on awareness/communication campaigns and research avenues. QVF will also be looped into conference calls and meetings so that we have an equal seat at the table from a patient's perspective. This is a big step and we are very proud to have opened these avenues.

 

None of this could have happened without your support and we thank you for helping to make all of this possible. We have made tremendous strides and we will continue to be your voice.

 

Baron & Budd: Quinolone Vigilance Foundation Director Meets with Senators, Urges Better FDA Oversight

Baron and Budd blog about QVF's meeting with Senators:

March 10, 2016

Rachel Brummert, executive director of the Quinolone Vigilance Foundation (QVF), recently met with U.S. Senators Thom Tillis and Richard Burr of North Carolina to urge increased scrutiny of the U.S. Food and Drug Administration (FDA). An article reporting the meeting appeared on the website of Charlotte TV station WSOC on Feb. 15.


According to the report, Brummert urged the senators to force the FDA to not only perform more aggressive follow-ups on drugs after they are approved, but also to form an oversight committee to watch the agency more closely. Brummert also wants the FDA to overhaul its Medwatch reporting program.

A Special Motivation
 
Brummert became involved in the QVF to increase awareness of the risks of a powerful class of antibiotics known as fluoroquinolones. She has first-hand experience of those risks, as she has had numerous tendon ruptures and even heart problems after taking a fluoroquinolone more than a decade ago.

These antibiotics, including Levaquin, Avelox and others, have been over-prescribed for several years. In many instances they are prescribed for relatively minor ailments such as sinus and ear infections even though they are designed to deal with much more severe infections.
One of the most serious complications linked to fluoroquinolones is a condition known as peripheral neuropathy, which can lead to permanent nerve damage. It can occur at any time after taking a fluoroquinolone. In fact, symptoms can begin within just a few days of taking the drug.

The disease causes damage to the nerves that help the brain and spinal cord communicate with the rest of the body. When this communication is interrupted, the results can be debilitating. They include a loss of reflexes, shooting pain, and a reduced sensation to pain, touch and temperatures. In extreme cases, paralysis can occur.

QVF Goes to Atlanta, Georgia

QVF executive director Rachel Brummert and QVF ambassador Jonathan Furman traveled to Atlanta, Georgia to meet with the Centers for Disease Control and Prevention, and for a television interview with WSB-TV. Joining them was Jeff Stephens, a gentleman disabled after taking Levaquin.

Following the CDC meeting, they went to WSB-TV to do a television interview.

QVF video about our Atlanta trip: https://www.youtube.com/watch?v=zfmFW37aR1Q

Consumer Reports: Fluoroquinolones Are Too Risky for Common Infections

Fluoroquinolones Are Too Risky for Common Infections

An FDA panel says popular antibiotics such as Cipro are overprescribed and should have stronger warnings about dangerous side effects

By Teresa Carr

March 07, 2016 

 

Last November, Rachel Brummert, 45, of Charlotte, North Carolina, stood before a panel of experts and described the ever-worsening series of health problems, including 10 ruptured tendons and progressive nerve damage, she’s suffered as side effects of taking the antibiotic Levaquin, a type of fluoroquinolone, for a suspected sinus infection in 2006.

The Food and Drug Administration convened the panel to consider whether the official drug labels for fluoroquinolones, a group of antibiotics that includes drugs such as Cipro and Levaquin, should be changed to more clearly spell out their risks and discourage overuse. Brummert, the executive director of the Quinolone Vigilance Foundation, was one of more than 30 people who spoke during the open public hearing portion of the meeting about how the drugs had an impact on their lives.
 “I am living proof that the risks in using a fluorquinolone to treat a routine infection far outweighs the benefits,” Brummert says.

 

After reviewing the evidence, the 21-member FDA panel agreed. They voted overwhelmingly that, in most cases, the benefit of fluoroquinolones to treat three common illnesses—bacterial sinus infections, urinary tract infections, and some forms of bronchitis in people with chronic lung disease—was outweighed by the risk of rare, but serious side effects, including irregular heartbeats, depression, nerve damage, ruptured tendons, and seizures.

Currently, those three illnesses account for nearly one-third of all fluoroquinolones prescribed outside of hospitals in the U.S. according to data presented by Janssen Pharmaceuticals, makers of Levaquin, at the FDA meeting.

While the fluroquinolones are essential for treating serious infections such as anthrax, the FDA panel members noted that they are overprescribed for common infections where other treatments would work just as well with less risk. They called on the FDA to strengthen labeled warnings and clarify when the drugs—should—and should not—be used.

Rampant Overprescribing

Over the last 30 years, the FDA has approved five fluroquinolone antibiotics to treat one or more of three illnesses considered by the panel: ciprofloxacin (Cipro), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin (Floxin), and gemifloxacin (Factive). All are also available as generics.
Much of the evidence on the risks of the drugs emerged after the drugs were on the market and used by millions of patients. While medical organizations such as the Infectious Diseases Society of America have updated their guidelines to advise against prescribing fluoroquinolones for milder garden-variety infections—including most cases of bronchitis, sinus infections, and urinary tract infections—many doctors haven’t gotten the message. That's likely because these powerful antibiotics work against a wide variety of bacteria, says Lindsey R. Baden, M.D., an infectious disease physician at Brigham and Women’s Hospital in Boston, Massachusetts, an associate professor at Harvard Medical School, and a member of the FDA panel. That can lead to overprescribing.

“Fluoroquinolones play an important role in treating serious infections such as those caused by bacteria that are resistant to other types of antibiotics,” says Baden. But in the case of less severe illnesses such as a mild bacterial sinus infection or uncomplicated bladder infection, the drugs “should typically be reserved for second-line or even third-line treatment after other antibiotics have failed,” says Baden.

When to Say 'No' to Cipro and Similar Drugs

Below we’ve listed three types of infections where fluoroquinolones are often not the best first choice for treatment along with our medical advisers’ advice about what to do instead.

• Sinus infections. “The vast majority of sinus infections are caused by a virus, not a bacteria and antibiotics don’t work against viruses,” says Baden. Even if bacteria are responsible, the infection will typically clear up on it’s own in a week or so. An antibiotic such as amoxicillin may be warranted if your symptoms last longer than a week, start to improve and then worsen, or are very severe—accompanied by a fever of 101.5 or higher, for example, or extreme pain and tenderness over your sinuses. For more information see Choosing Wisely recommendations from the American Academy of Allergy, Asthma, and Immunology.
• Urinary tract infections (UTIs). If you have symptoms of a urinary tract infection such as having to urinate frequently, pain or burning when you go, cloudy or bloody urine, and a fever, you may need an antibiotic to treat the infection. Several types of antibiotics are effective against uncomplicated bladder infections; fluoroquinolones are typically only necessary if the infection is resistant to other antibiotics or has spread to the kidneys. Note that people aged 65 and older often have bacteria in their urine, but do not need to be tested or treated for a UTI unless they have symptoms. For more information see Choosing Wisely recommendations from the American Geriatric Society.
• Bronchitis. As with sinus infections, most cases of bronchitis, or chest colds, are caused by a virus and are not helped by taking an antibiotic. (Read our advice on what to do ease symptoms while your body fights the infection.) One exception: patients with chronic obstructive pulmonary disease (COPD), a condition that causes difficulty breathing, may benefit from antibiotics if they develop symptoms severe enough to require hospitalization. In that case, the best choice of drug depends on the several factors, including which bacteria are prevalent in your area. For more information on using antibiotics to treat respiratory illness in children see Choosing Wisely recommendations from the American Academy of Pediatrics.

All Antibiotics Have Risk

Brummert says she hopes that the FDA will act on the advisory panel’s recommendations. “Curbing unnecessary prescribing of fluoroquinolones could save thousands of Americans from needless suffering,” she says.

Baden points out that all antibiotics—not just fluoroquinolones—should be used more thoughtfully.
“Really, I think the labels for all antibiotics should be strengthened to remind doctors and patients that when the drug is unwarranted, prescribing it has no benefit and exposes patients to needless risk, however small that risk may be,” says Baden. “Antibiotics are overused; as a community we need to be having these conversations about better prescribing based on the balance of benefits to harms.”

Editor's Note: This article and related materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

 

 

 

FDA Commissioner nominee Dr. Robert Califf a Threat to Patient Safety

FDA Commissioner nominee Dr. Robert Califf a Threat to Patient Safety

On February 22, 2016, the US Senate will hold a cloture vote for the Senate confirmation of Dr. Robert Califf as Commissioner of the Food and Drug Administration (FDA).

The Quinolone Vigilance Foundation sent the following letter to US. Senator Richard Burr, who is on the HELP Committee.

As you may recall, QVF met with Senator Burr’s office in Washington, DC on February 3. One of many things QVF brought up was fluoroquinolones, failure on the part of the FDA, patient safety and preventable medical harm, and the possible confirmation of Dr. Califf.

February 11, 2016

Senator Richard Burr

217 Russell Senate Office Building

Washington, DC 20510 

 

Dear Senator Richard Burr,

 

As a patient who has been irrevocably harmed by a dangerous fluoroquinolone antibiotic, and as the Executive Director of the Quinolone Vigilance Foundation, I am writing to express deep concerns over the impending cloture vote on February 22, 2016 for the Senate confirmation of Dr. Robert Califf as Commissioner of the Food and Drug Administration (FDA).

 

Three United States Senators have placed a hold on the Senate confirmation of Dr. Califf. Despite that, the Senators who have said they will block such a vote have done so, not out of political contentiousness, but rather from grave concerns over Dr. Califf’s ability to provide the kind of leadership that the FDA needs to protect the health and safety of the American people.

The New York Times recently stated, “Califf has ‘deeper ties to the pharmaceutical industry than any F.D.A. commissioner in recent memory.’ The threats to patient safety are enormous and alarming.

A Xarelto study led by Dr. Califf came under sharp criticism by the FDA as having a built-in bias in favor of this new, more expensive blood thinner. Although eventually approved, Xarelto is now the subject of mass litigation for causing untold injury and death. 

 

Sources:

http://www.pogo.org/blog/2015/11/fd...

http://cardiobrief.org/2015/11/30/n...

 

Dr. Califf has said that he will not lower FDA standards. Yet a recent New York Times editorial states that “In 2014, Dr. Califf gave a speech to researchers, lawyers and industry experts in which he described regulation as a 'barrier' to biomedical innovation. He also helped author a series of papers which were critical of the FDA, and had his name removed from those papers in close proximity to when he was nominated for the Commissioner position. Dr. Califf has recently come under scrutiny for providing the Senate HELP Committee members with questionable answers.

 

Sources:

http://www.raps.org/Regulatory-Focu...

http://www.pogo.org/blog/2016/02/fd...

 

If Dr. Califf is confirmed, there is grave concern that he will jeopardize patient safety and further lower the integrity of the FDA review process. Patients need a Commissioner who will provide reasonable assurance of the safety and efficacy of our drugs and devices through the gold standard of double-blind, human clinical studies. Therefore, I and other patients who have been harmed by toxic fluoroquinolone antibiotics, call on the Senate to prioritize patients above industry groups, to put the integrity of the scientific process above profits, and decline to confirm the nomination of Dr. Robert Califf as Commissioner of the FDA.

Respectfully,

Rachel Brummert, Executive Director

Quinolone Vigilance Foundation

www.SaferPills.org

Charlotte, North Carolina 28213

QVF Goes to Washington, DC- February 1-3, 2016

Rachel Brummert, executive director of QVF, and Jonathan Furman, QVF ambassador, went to Washington, DC February 1-3.

On February 1, they attended a dinner and met 40 patient safety advocates from across the country.

February 2 was a busy day. Ms Brummert and Mr Furman attended the Safe Patient Summit. They learned a lot, were given access to resources, listened to guest speakers, participated in round table discussions, and networked with journalists and Public Citizen.

February 3, Mr Furman and Ms Brummert met with legislators in the United States Senate and United States House of Representatives. They were also interviewed for two television news stories which aired in Charlotte, North Carolina, and Richmond, Virginia.

WSOC-TV interview: http://www.wsoctv.com/news/action-9/charlotte-woman-urges-senators-to-police-fda-better/85490802 

WRIC-TV interview: http://wric.com/2016/02/07/federal-lawsuit-filed-against-former-fda-commissioner/

After their meetings with legislators, they attended a vigil for those harmed and killed by medical harm. It was filmed by documentary filmmakers.

QVF video about our visit to Washington, DC: https://www.youtube.com/watch?v=0Qm7M4KpQq0

Guest blog for Consumers Union- A Cautionary Tale: Dangers of Antibiotic Overuse

Rachel Brummert, executive director of the Quinolone Vigilance Foundation wrote a guest blog for Consumer's Union.

http://safepatientproject.org/posts/5609-a-cautionary-tale-dangers-of-antibiotic-overuse

January 5, 2016

A Cautionary Tale: Dangers of Antibiotic Overuse

 

Guest post by Rachel Brummert, Executive Director, Quinolone Vigilance Foundation
rachel@saferpills.org

Patients seeking relief from a sinus infection, uncomplicated urinary tract infection, or bronchitis should never become injured or disabled from medications that are supposed to help them.
But that is exactly what happens to millions of people worldwide when they are prescribed a powerful fluoroquinolone antibiotic like Cipro (ciprofloxacin), Levaquin (levofloxacin), or Avelox (moxifloxacin) for routine infections which do not need their strength and for which there are safer alternatives.

Fluoroquinolones are a class of broad spectrum antibiotics that are incredibly powerful with the capability to save lives when used appropriately as a treatment of last resort for life-threatening bacterial infections like anthrax. But these antibiotics also have equal power to destroy lives when they are inappropriately prescribed for routine infections, which don’t need their strength. Prescribing an antibiotic strong enough to treat anthrax for a simple infection is like detonating an atomic bomb to kill a mosquito. Fluoroquinolone antibiotics are associated with severe adverse reactions, which may be permanent and life-threatening.

As the number of prescriptions for fluoroquinolone tablets, IV, eye drops, and ear drops have increased, so have the number of adverse reactions reported to the FDA. These adverse reactions encompass several body systems including the peripheral, autonomic, and central nervous systems, psychiatric, cardiovascular, musculoskeletal system, and more.

The FDA is taking notice of this. The agency has issued a “black box” warning to prescribers of the drug. And in a recent review, the FDA refers to this constellation of symptoms in previously healthy individuals as “fluoroquinolone-associated disability”.

That is exactly what happened to me. I went to my doctor for treatment of a routine sinus infection and instead I was inappropriately prescribed an antibiotic that has disabled me. According to the CDC, up to 50% of all the antibiotics prescribed for people are not needed or are not optimally effective as prescribed.

On November 5, 2015, I was honored to testify at the FDA Joint Meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The panel discussed the risk/benefit ratio of fluoroquinolone antibacterial drugs for the treatment of routine infections. I shared my story of how I was an otherwise healthy individual who was prescribed Levaquin for a routine sinus infection in 2006 and became disabled with ten tendon ruptures, peripheral neuropathy, cardiac problems, and a progressive neurodegenerative disorder from which I will never recover.  My sinus infection would have resolved had I been prescribed a safer alternative and I would not have been exposed to the relatively disproportionate risks of known fluoroquinolone-associated injury.

The hearing took place at the FDA White Oak Campus in Silver Spring, Maryland, the same building and conference room as the Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Hearing on March 27, 2015 at which I testified about how the Pliva v Mensing Supreme Court decision prevents victims harmed by generic fluoroquinolones from pursuing legal action against their makers and how patients are being harmed unnecessarily because generic drug makers are not required to update the safety information on generic drugs.

At the November FDA hearing, 35 people, including me, testified in front of the twenty-one member FDA advisory panel, each sharing their emotional, gut-wrenching stories of how fluoroquinolone antibiotics caused them, or someone they love, irreparable harm. Among them was a woman who lost her son, a man who lost his brother, and dozens of victims who once led healthy, productive lives and can no longer enjoy a reasonable quality of life.

The advisory panel agreed that the risks outweigh the benefits when fluoroquinolone antibiotics are inappropriately prescribed for routine infections and they voted 21-0 for a label revision on sinusitis, 20-1 for UTIs, and 18-2 with one abstention for bronchitis.

Advocating for victims of fluoroquinolone antibiotics, promoting patient safety, educating patients and the medical community, and engaging in research is our primary goal at the Quinolone Vigilance Foundation, and we applaud the FDA advisory panel for taking steps in the right direction to protect patients from preventable harm. By recommending limiting fluoroquinolone antibiotics to life-threatening infections and not prescribing them for routine infections, patients will be protected from life-long injury and disability, and it will help combat antibiotic resistance, a growing world-wide epidemic. These are steps in the right direction because a preventable problem is a fixable problem.