Has Levaquin Ruined Your Life?
By Mary Sparrowdancer
c. 2012 All Rights Reserved
5-4-12
 

John Fratti alleges that Levaquin, a fluoroquinolone antibiotic marketed by Johnson & Johnson (JNJ, J&J), had that exact effect on him: It ruined his life.

Mr. Fratti had been a healthy, athletic young man of 41, when he presented to his doctor's office in May, 2005, for a possible UTI and was prescribed Levaquin. After taking a second course of Levaquin in August, 2005, he began experiencing aches and pains that grew progressively worse over the following months. During that time he also developed other symptoms including vision problems, petite mal seizures, suicidal thoughts, insomnia, impaired circulation, severe fatigue, equilibrium problems, sound sensitivity, neuropathy, and tendinitis so severe at times he could not walk.

Far from being alone in experiencing what cutting-edge physicians are finally recognizing as "Levaquin-induced" toxicities, the other victims number in the unknown thousands, unknown because their cases rarely make mainstream media news. Their symptoms have been similar to those of Mr. Fratti, and over one thousand deaths have been noted, and the general population remains unaware of the dangers of fluoroquinolones, which are fluorinated antibiotics. Adding to the problem is the fact that "Levaquin-induced" toxicity can show up weeks, months and even longer after the patient has stopped taking the Levaquin, although many physicians do not realize this.

John Fratti, who received his MBA from James Madison University, went from a life excelling in sports such as basketball and racquetball, and excelling in his profession as a pharmaceutical sales rep, to being wheelchair-bound for several months, disabled and jobless. A skin punch biopsy at Johns Hopkins University noted unusual axonal nerve swellings and tears, and MRIs and a QEEG test noted abnormal brain function. John Fratti's diagnosis was "Levaquin-induced toxicity."

One might assume that a pharmaceutical representative might have been forewarned about taking a drug so dangerous that it can cause a lifetime of irreversible agony, but the bitter irony is that not even the representatives have been made fully aware of the flaws and dangers in many of the drugs they are selling, due to what Mr. Fratti alleges are deceptive marketing practices.

A "black box warning" was finally issued by the Food and Drug Administration (FDA) for fluoroquinolones in July, 2008. The warning came years too late for John Fratti and the thousands of others who innocently took a prescription in compliance with doctor's orders, only to find themselves severely damaged as a result. In addition, there is still no guarantee that the patients will be made fully aware of the "black box" adverse effects advisory prior to being given a prescription. Media must be used to raise awareness, and this is now the goal of Mr. Fratti in order to prevent others from suffering his fate. "If I can prevent others from suffering from this toxicity, it makes my life more worthwhile," he stated in a recent interview with Ed Silverman of Pharmalot.

Mr. Fratti began thoroughly researching the history of Levaquin, filing a Freedom of Information (FOI) request with the FDA for Adverse Events information for Levaquin. The FDA's MedWatch report that he received, titled, "Adverse Event Reporting System (AERS), Freedom of Information (FOI) Report, Selections for: Levofloxacin, Levaquin, From: 01-Nov-1997 to: 20-Jan-2010," with the disclaimer that the data cannot be used to estimate the incidence of adverse drug reactions.

The report indicates that there were 61,983 reactions reported to the FDA for Levaquin/levofloxacin, including over 1000 deaths, although this is apparently just a fraction of the actual reactions to Levaquin. According to a US Government Accounting Office (GAO) report to Congress, the FDA's Adverse Event Reporting System (AERS) is a voluntary one, and "includes an estimated 1 to 10 percent of adverse events." The FDA Report showed reactions that included joint pain, renal failure, insomnia, rhabdomyolysis, tendinitis, tendon rupture, headache, anxiety, pneumonia, vomiting, deafness, suicidal ideation, fibromyalgia, blindness, hallucinations, pancreatitis, diarrhea, leg amputations, foaming at mouth, tinnitus, abnormal liver function, heart attack, aggression, brain death, spontaneous abortion, death and "agonal death struggle" - dying in agony. This is a short list of only 27 reactions out of the total 61,983 reported in the FOI report, which in turn is only "an estimated 1 to 10 percent of adverse events."

In a Levaquin Approval Document from Johnson & Johnson to the FDA, Levaquin was approved on 12/20/1996. It was approved despite the fact that the FDA medical officer's conclusions state that there were significant flaws in both the protocol design and implementation of several of the studies for which its approval was based. The medical officer noted that the clinical assessment categories were inappropriate.

In an email to Sandra Bartlett of NPR, Mr. Fratti noted that, "JNJ Clinical Trials indicated that a sizeable percentage of Levaquin adverse events were delayed, starting many days after the last Levaquin dose. Because of this, many people do not realize that the health problems they are experiencing such as nerve, tendon and joint pain, and mood disorders may be the result of taking Levaquin. Although JNJ Levaquin Clinical Trials clearly showed that a sizeable number of adverse events may be delayed, JNJ fails to warn patients and physicians of delayed adverse events on the Levaquin label (with the exception of tendon issues and diarrhea.)"

Mr. Fratti went on to note that while the JNJ Clinical Trials only contained a few types of adverse events, the first label after Levaquin was approved listed dozens of adverse events. "It would appear," Fratti stated, "that JNJ knew there were dozens of adverse events, but JNJ failed to mention these extensive other adverse events in its Clinical Trials."

A shareholder proposal that was submitted to JNJ from a firm called "Harrington Investments," requested that JNJ address the health and social welfare concerns of people harmed by Levaquin, and reported that a news segment aired by PBS showed a young teacher named Jenne Wilcox who could no longer walk or work after taking Levaquin. The same PBS program included footage of John Fratti, who also lost his job after taking Levaquin. It states that "Senator Harkin and Senator Grassley's offices have begun an investigation into whether the FDA should issue more safety warnings for Levaquin." In addition, Mr. Fratti received letters from other elected officials, including more members of Congress promising to try and do something about Levaquin.

One must question why it is necessary for Congress and even the FDA to address something that is in reality the sole responsibility of Johnson & Johnson for marketing a potentially harmful and deadly product. This is particularly troubling when Johnson & Johnson's credo states, "We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services."

In order to direct this question about credo adherence to the Johnson & Johnson board of directors, John Fratti bought enough JNJ stock in 2008 to make him eligible to attend a JNJ shareholder meeting in April, 2009. It was difficult for him to travel due to his Levaquin-induced injuries, but he made the trip and was allowed to speak.

"What I wanted to do," Fratti said during Mr. Silverman's interview in reference to why he had made that difficult trip, "was address the CEO and the board of directors about Levaquin to see if they would put further safety warnings on Levaquin.I made sure to be very civil as I want to be able to try attending the yearly shareholder meeting as often as possible." In his speech to the Johnson & Johnson shareholders and CEO, he mentioned the famed J&J credo, as well as the fact that in the JNJ shareholder booklet, JNJ claimed to be "caring for the world one patient at a time."

"Well, at that moment, I was that one patient." John Fratti said.

When he finished his speech, there was a loud round of applause by the shareholders. The previous year, Mr. Fratti states another injured person gave a speech to the CEO and directors of JNJ. His speech received a standing ovation from the JNJ shareholders.

After Mr. Fratti's speech in 2009, CEO William Weldon took a moment to sit and speak with Mr. Fratti while the eyes of the moved shareholders, media and investors looked on. Mr. Fratti states that he told Mr. Weldon more about his situation, that he had been in a Levaquin documentary called "Certain Adverse Events," and that he did not want others to suffer the way he had. Mr. Weldon told Mr. Fratti that he would "look into this and try to help." He took the information Mr. Fratti gave to him and walked away.

"And we haven't heard anything from him," Mr. Fratti said.

In response to this oversight or perhaps wanting to believe Johnson & Johnson's famous and often repeated vow of moral responsibility to patients as well as mothers, Fratti's mother, Katherine Fratti, a retired RN, wrote a letter to William Weldon reminding him of everything her son had lost after taking Levaquin. There was no audience to watch his response the letter, and William Weldon passed the responsibility for that mother's concerns on to the J&J "Office of General Counsel." Someone named "John O'Shaughnessy" wrote back to Mrs. Fratti stating, "Dear Ms. Fratti: Bill Weldon has referred to me your recent letter concerning your son John. As Bill stated at our Annual Meeting last year, we are all very sorry about the health issues confronting your son and understand your deep concern for him."

That was the extent of the first paragraph, perhaps indicating that there was actually very little understanding of one mother's "deep concern" for her son's ruined health and life. O'Shaughnessy then stated that he could not respond "substantively" to her letter, "in light of the fact that your son has instituted a lawsuit." With the eyes of the shareholders, the media, and investors no longer watching, Bill apparently washed his hands of that "first responsibility," promised in the JNJ credo.

Mr. Fratti has most recently been interviewed by investigators of the FDA's Office of Criminal Investigation, who became interested in Levaquin events after the elected officials who responded to Mr. Fratti's letters wrote to the FDA. Part of the problem regarding the lack of product safety, is undeniably the "revolving door" situation within regulatory agencies in Washington, D.C. Through those "revolving doors," corporate representatives move easily from large firms into government agencies, spend time regulating their own products, and then return to lucrative positions back within the firms. The main goal in such a scenario obviously cannot be consumer safety.

A statement found on Johnson & Johnson's website declares, "About Johnson & Johnson, one person at a time.inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Our approximately 114,000 employees at more than 250 Johnson & Johnson companies work with partners in health care to touch the lives of over a billion people every day, throughout the world."

John Fratti is still unable to live a normal life, work, or play sports. He remains in constant pain. On April 26, 2012, he spoke again in a shareholder's meeting, asking that JNJ provide more safety warnings about Levaquin. He still wants the "research and science" they claim to embrace to restore his health and the health of the many thousands of others who have and are suffering in this current national calamity - a calamity in which lives have indeed been "touched" by another product originating from Johnson & Johnson, a monopolistic mega-firm that apparently remains untouchable.

Bill stepped down as CEO on April 26, 2012, but he took a moment once again to sit and speak with John Fratti, saying again that he would like to help Mr. Fratti and now stating that because he is retired, he would have more time to do so. Bill mentioned possibly researching the genetic component that makes some people more susceptible to the injuries from Levaquin, and he stated again that he truly did care. "I hope he follows though on his pledge to initiate medical research on this important health issue," John Fratti said. Taking over as the new CEO of Johnson & Johnson is Alex Gorsky.

Promising headlines following the recent changing of CEOs include, "New J&J CEO Plans Realistic, Optimistic Future," and that Gorsky is presenting a reassuring front, vowing to adhere to the values and responsibilities contained in the famous J&J credo.

According to the US Department of Justice (DOJ), the DOJ brought a lawsuit against JNJ in 2010, alleging illegal "kickbacks" that resulted in false Medicaid claims, and questionable marketing practices for J&J's fluorinated antipsychotic, Risperdal, as well as Levaquin and other J&J drugs. DOJ alleges J&J conspired with Omnicare, Inc. to promote J&J drugs above all other brands in nursing homes. The DOJ further alleges that Alex Gorsky was vice president of sales and marketing and then president of J&J's Janssen unit during the time of investigation, that Gorsky has "relevant knowledge" concerning the matter, and that the DOJ wishes to question Gorsky under oath.

As of April, 11, 2012, J&J refused to make Gorsky available to testify.

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Mary Sparrowdancer is an internationally published book author, and an investigative journalist in Tallahassee, Florida. She is a columnist for Jeff Rense at rense.com. She has over 30 years of study in laboratory science, including 20 years study of rabies, and over nine years studying the damaging effects of fluoride. She writes about medicine, health, science, nutrition, gardening and politics. In 2004, she contacted JNJ's Ortho-McNeil, then-manufacturer of Levaquin, essentially putting them on notice that Levaquin contained an extremely high level of fluoride, and asking their "medical expert" how much of the fluoride was bio-available after ingestion. The "expert" as well as a chemist laughed and said, "None. You don't get fluoride from Levaquin, you get it from toothpaste and drinking water." Clinical tests in India have proven otherwise. The reactions to Levaquin (and Cipro) are similar to those of fluoride poisoning.

Mary's son is currently campaigning for a seat in the Florida Senate. Her daughter is a Deputy Sheriff.

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References:

Black Box Warning for Fluoroquinolones

http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm126085.htm

FDA's Adverse Event Reporting System

http://www.fda.gov/ohrms/dockets/dailys/04/apr04/042304/03n-0324-bkg0002-09-Tab-07-vol3.pdf


FDA and Levaquin

http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020634_levaquin_toc.cfm


PBS Newshour Interview with John Fratti and Others

http://www.pbs.org/newshour/bb/health/jan-june11/antibiotics_06-16.html


Interview with Ed Silverman

http://www.pharmalot.com/2012/02/levaquin-causes-a-lot-of-damage-fratti-explains/


Documentary Featuring Mr. Fratti

http://www.certainadverseevents.com/home.html


One Person at a Time

http://www.jnj.com/connect/NewsArchive/financial-news-archive/Johnson-Johnson-Reports-2010-Third-Quarter-Results


Bill

http://www.usatoday.com/money/industries/health/drugs/story/2012-02-21/johnson-and-johnson-ceo-weldo

http://www.boston.com/business/articles/2012/04/26/jj_execs_reassure_shareholders_on_quality_issues/


DOJ Brings Lawsuit against JNJ for "kickbacks."

http://www.justice.gov/opa/pr/2010/January/10-civ-042.html


Alex Gorsky

http://articles.chicagotribune.com/2012-04-13/business/sns-rt-us-jj-gorskybre83d00g-20120413_1_risperdal-omnicare-arkansas-state-judge


DOJ Alleges J&J Party To Medicaid Fraud

http://www.justice.gov/usao/ma/news/2010/January/JJ/J&J%20complaint%20--%20filed.pdf


Realistic Optimistic Future

http://abcnews.go.com/Health/wireStory/jj-ceo-plans-realistic-optimistic-future-16213853#.T518fFKAPKR


Editorials, blogs, and statements from victims of Levaquin:

Star Ledger Editorial on JNJ: Big Company, Small Morals.

http://blog.nj.com/njv_editorial_page/2012/02/johnson_johnson_another_exampl.html


John Fratti's Website

www.Levaquinadversesideeffect.com


Harmed by Levaquin

http://www.facebook.com/media/set/?set=a.209189629106084.55463.209182505773463&type=3

www.Saferpills.org

 

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