The United States Attorney’s Office

District of Massachusetts

FOR IMMEDIATE RELEASE
JUNE 18, 2009
WWW.USDOJ.GOV/USAO/MA

CONTACT: CHRISTINA DiIORIO-STERLING
PHONE: (617)748-3356
E-MAIL: USAMA.MEDIA@USDOJ.GOV

PHARMACEUTICAL COMPANY MANAGER SENTENCED FOR OFF-LABEL MARKETING

BOSTON, MA – A Branchburg, NJ, woman was sentenced today for violating the Food, Drug and Cosmetic Act, for marketing the drug Bextra for uses and dosages that were not approved by the Food and Drug Administration.

Acting United States Attorney Michael K. Loucks; Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division; Susan J. Waddell, Special Agent in Charge of the Department of Health and Human Services, Office of Inspector General; Leigh-Alistair Barzey, Resident Agent in Charge of the Defense Criminal Investigative Service; Kim A. Rice, Special Agent in Charge of the U.S. Food and Drug Administration, Office of Criminal Investigations, Metro Washington Field Office, Special Prosecution Staff; Jeffrey Hughes, Special Agent in Charge of the U.S. Department of Veterans Affairs, Office of Inspector General, Office of Investigations – Northeast Field Office; and Joseph Finn, Special Agent in Charge of the United States Postal Service, Office of Inspector General, Boston Field Office, announced today that MARY HOLLOWAY, age 47, of Branchburg, New Jersey, has been sentenced by United States Magistrate Judge Judith Dein to pay a $75,000 fine and twenty-four months of probation after pleading guilty to an Information charging her with distribution of a misbranded drug.

At the plea hearing, prosecutors told the Court that, had the case proceeded to trial the Government’s evidence would have proven, the following:

From approximately November 2001, through April 2005, HOLLOWAY was employed as a Regional Manager at a pharmaceutical company and was responsible for sales in her region of the drug Bextra. Bextra was a Cox-II inhibitor and had been approved in by the Food and Drug Administration (FDA) in November 2001 for the signs and symptoms of osteoarthritis, adult rheumatoid arthritis, at 10 mgs and primary dysmennorhea at 20 mgs, twice a day as needed. In 2001, the FDA specifically denied the request of the pharmaceutical company to approve it for acute pain, including the pain of surgery. The FDA told the pharmaceutical company that it could not approve it for these other indications because the safety in these other uses had not been established. Specifically, the FDA was concerned about the results of a study in which there was an excess of cardiovascular events in patients who had undergone coronary artery bypass graft surgery and used Bextra.

HOLLOWAY was aware of the FDA’s safety concerns, but that she nonetheless had her sales staff of approximately 100 employees sell Bextra for precisely the uses that the FDA refused to approve. For example, HOLLOWAY trained and encouraged her sales teams to promote Bextra by obtaining protocols from doctors that instructed that Bextra be used for the pain of surgery, an unapproved use, and at 20 mgs, an unapproved dose. HOLLOWAY also instructed her staff to market Bextra for use before, during and after surgery to reduce the risk of deep vein thrombosis, which is a form of life threatening blood clots, even though she knew there were no studies showing that Bextra was safe and effective for this use. Finally, HOLLOWAY encouraged her staff to make false safety claims about Bextra in order to sell the drug.

Acting United States Attorney Michael K. Loucks said, “We will continue to hold individuals responsible for their conduct in promoting pharmaceutical drugs outside of the uses for which they have been found to be safe and effective by the United States FDA. The conduct at issue here undermined the FDA’s regulatory scheme and put patients at risk for the purpose of pursing profits for the individual and the pharmaceutical company.”

Bextra was withdrawn from the market in April 2005.

The case was investigated by the Federal Bureau of Investigation, the Office of Inspector General for the Department of Health and Human Services, Special Prosecutions Staff for the U.S. Food and Drug Administration, Office of Inspector General for the Department of Veterans Affairs, the Defense Criminal Investigative Service, and the Office of Inspector General for the United States Postal Service. It was prosecuted by Assistant U.S. Attorneys Sara Miron Bloom and Susan M. Poswistilo of Loucks’ Health Care Fraud Unit.

©2012 An Inconvenient Woman. All Rights Reserved.

©2012 An Inconvenient Woman. All Rights Reserved.

WASHINGTON  The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care professionals as early as possible.

The list includes a wide array of drugs, from Eli Lilly & Co. s antidepressant Cymbalta to Purdue Pharma LPs painkiller Oxycontin. It also addresses a range of adverse reactions, including cardiac arrest, cancer and Purple Glove Syndrome, which can result in patients having their arms amputated. (See the FDA s list of drugs that are under investigation.)

The FDA has already sent out warnings about a handful of the drugs on the list. The report lists TNF blockers  such as Johnson & Johnson s Remicade  as being potentially associated with cancer in children. In June, the FDA said it was investigating the possible link. TNF blockers target a compound known as tumor necrosis factor, which is overproduced in many patients with inflammatory diseases like arthritis and Crohn s.

But there appear to be new ones, too. The report lists Biogen Idec Inc. and Elan Corp. s multiple-sclerosis treatment Tysabri as potentially being associated with skin cancer. Medical journals have reported cases of melanoma in patients taking Tysabri, but the FDA hasn t previously said it was investigating the drug for this side effect.

The list, which the FDA will start issuing quarterly, is aimed at giving consumers and health-care professionals early indications of what the FDA is investigating, but it might end up creating more confusion. Indeed, the agency is concerned that people will stop taking a drug inappropriately  because it is on the list, said Paul Seligman, associate director of safety policy at the agency.

The FDA said it alerted companies whose drugs appeared on the list prior to it being made public  several companies said they received word late Thursday  and intends to give drug makers a heads-up in the future as well.

Drug makers said they support the FDA s additional efforts to be transparent about drug safety, but some expressed concern that the information was being communicated to patients without context and wondered about what patients might do with the information.

It is very, very important that patients and their physicians understand the benefits and the risks of the drug. To speak about one without the other could have an impact on patient perception of their medications,  said Tony Jewell, a spokesman for AstraZeneca PLC, whose psychiatric medication Seroquel made the list for the possible safety concern of overdose due to confusing sample-pack labeling.

Companies also cautioned that just because a drug is posted on the site doesn t mean a causal relationship has been identified, and it is also risky if patients go off their medications without consulting a physician.

The FDA s intention is for patients and doctors to use the list to be aware of potential adverse events and to encourage them to report any problems. The list doesn t represent a comprehensive list of drugs the FDA is investigating, the FDA s Mr. Seligman said.

The report is generated from the agency s adverse-event-reporting database. That compilation consists of voluntary reports from patients and health-care professionals, and is widely considered to capture only a fraction of the actual adverse events associated with any given drug.

Mr. Seligman said the FDA is hopeful the quarterly reports will encourage people to report adverse events.

Write to Jared A. Favole at jared.favole@dowjones.co

©2012 An Inconvenient Woman. All Rights Reserved.

WASHINGTON–(BUSINESS WIRE)–The National Vaccine Information Center (NVIC) is calling on the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) to publicly release the study design, data and names of principal investigators involved in a statement this week maintaining that Gardasil vaccine is safe with no serious side effects. NVIC will also be calling on the newly elected President and members of Congress to remove the nation’s vaccine safety monitoring system from the Department of Health and Human Services (DHHS) and place it in a separate entity reporting directly to Congress to restore trust in the nation’s public health laws based on federal mass vaccination policies.

The CDC and FDA are alleging that the vast majority – if not all – of the approximately 9,000 HPV vaccine adverse events, including 27 deaths, reported to the federal Vaccine Adverse Event Reporting System (VAERS) are not causally related to the Gardasil vaccine based on internal analysis, including review of medical records of girls and women vaccinated in HMO’s participating in the federal Vaccine Safety Datalink (VSD) Project and other closed government operated databases.

“Transparency in government is essential to trust in government and replication is the hallmark of good science,” said NVIC co-founder and president Barbara Loe Fisher. “Parents of young girls and women cut down in their prime – some of them paralyzed or dead within hours or days of getting Gardasil vaccine – deserve better answers than a whitewashing of this vaccine’s very serious side effects. Until there is an independent confirmation of these unverified findings by individuals and companies without financial ties to the government or industry, it is not credible.”

* In June 2006 NVIC questioned the quality and quantity of Merck’s pre-licensure Gardasil vaccine safety data in girls under age 16 and, in 2007, issued three reports analyzing serious Gardasil adverse events reported to VAERS;

* In 2007, Merck lobbied in many states for Gardasil vaccine mandates but failed in most;

* During 2008, about 20 percent of all vaccine adverse event reports to VAERS were related to Gardasil even though it is not a mandated vaccine like most others;

* Last week, reports that Merck’s Gardasil sales are falling dramatically and are not offsetting similar declining sales of other drugs associated with safety concerns prompted Merck to lower profit projections and layoff employees.

NVIC (www.nvic.org) was founded in 1982 and worked with Congress on the 1986 National Childhood Vaccine Injury Act. The non-profit watchdog group advocates for safer vaccine policies and the legal right for Americans to make informed, voluntary decisions about vaccination.

©2012 An Inconvenient Woman. All Rights Reserved.

Dr. Dan Roden is professor of medicine and pharmacology, director of the Oates Institute for Experimental Therapeutics, and assistant vice chancellor for personalized medicine at Vanderbilt University School of Medicine.

The Food and Drug Administration recently announced a public Web site listing potential drug side effects it is investigating. This move does seem to be in the public interest; after all, shouldn’t we know about drug side effects that are concerning enough to warrant an FDA investigation?

On further reflection, this turns out to be a pretty complicated question, and raises important issues about how doctors and patients should evaluate new information about the risks and benefits of drugs we use.

Before a drug is approved for marketing, it is tested in several thousand patients, and common side effects are identified. However, some side effects are only discovered after a drug is marketed. Some of these are so rare they just didn’t happen before a drug was approved. Others don’t turn up until they are identified in large, carefully conducted trials: An increase in heart-attack risk with Vioxx is a recent example.

There is no organized system in the United States, or elsewhere, to systematically examine the safety of marketed drugs. For many years, the FDA has run a voluntary adverse-events reporting system (AERS) that allows health-care providers and patients to describe possible side effects.

While AERS may generate clues to new side effects, the reports are often incomplete and may raise more questions than they answer. Is the rare effect really caused by the drug? What happens if a few people report something common, like an ulcer or a heart attack? How many people would have to report something before the FDA should get interested?

More reports often help

What is clear is that some of the 400,000 AERS reports submitted each year may represent real side effects, and others do not. One argument says that until further studies understand whether a drug actually causes a side effect, making a suspicion public would be counter-productive; for example, patients benefiting from the drug might stop needlessly.

I see a potential benefit to publicizing AERS reports that the FDA is investigating. Suggesting tenuous relationships between drugs and unusual side effects may prompt other physicians or consumers to recognize that they, too, may have seen (or been) similar cases. More reports do not establish cause and effect, but have helped in the past.

I also see an opportunity for coupling this kind of reporting to increasing public awareness of the risks vs. the benefits of treatment with any drug. An aware public will understand that because the FDA is investigating a potential relationship does not establish that a relationship even exists.

There is no drug that is 100 percent effective and never causes side effects. What we don’t want are drugs where the risks are much greater than the potential benefits, or where we can’t pick out the people at high risk for serious side effects. The new reporting system may, therefore, be one small step toward identifying unsafe drugs.

©2012 An Inconvenient Woman. All Rights Reserved.

Gardasil® Deaths, Gardasil® Side Effects, Gardasil® Paralysis -

Is the HPV Vaccine Given to Prevent Cervical Cancer Causing More Medical Problems?

A vaccine designed to prevent cervical cancer is coming under fresh scrutiny amid thousands of complaints linking it to a range of health problems.

Gardasil® has been the subject of 7,802 “adverse event” reports from the time the Food and Drug Administration approved its use two years ago, according to the Centers for Disease Control and Prevention.

Girls and women have blamed the vaccine for causing ailments from nausea to paralysis — even death. Fifteen deaths were reported to the FDA, and 10 were confirmed, but the CDC says none of the 10 were linked to the vaccine. The CDC says it continues to study the reports of illness.

Gardasil prevents the spread of human papillomavirus, known as HPV — a sexually transmitted virus that can cause cervical cancer in a relatively small number of girls and women.

The vaccine’s manufacturer, Merck & Co. Inc., says it has distributed more than 26 million Gardasil® vaccines worldwide, including nearly 16 million in the United States. It estimates that 8 million girls and women have received the vaccine in the United States since June 2006. V

Two girls allege in court that the vaccine made them sick.

One — Jesalee Parsons of Broken Bow, Oklahoma — got the shot at age 13.

Jesalee’s lawyer, Michael McLaren, said she got the shot on February 27, 2007 and soon developed a fever and felt pain. The next day, he said, Jesalee felt pain in her chest and abdomen.

Her mother, Laura Parsons, said Jesalee spent weeks in the hospital and underwent two surgeries after developing pancreatitis. She says the federal government should have studied the drug more before approving its use.

“I just feel let down by the government,” Parsons said.

Merck says it could be a coincidence that the girls got sick after receiving the vaccine.

The company said in a statement that an adverse event report “does not mean that a causal relationship between an event and vaccination has been established — just that the event occurred after vaccination.”

Merck said it would continue to evaluate reports of adverse reactions. It said it “updates product labels with new safety information as appropriate.”

Watch more on complications linked to Gardasil »

For Full Article and more video go to:

http://www.cnn.com/2008/HEALTH/conditions/07/07/cervical.cancer.vaccine/

A sincere thank you to major media outlets, CNN, the Washington Post and the New York Times, for following and reporting the Gardasil® adverse events and asking probing questions about the safety and effectiveness of this aggressively-marketed Merck product.

©2012 An Inconvenient Woman. All Rights Reserved.

Addressing Questions About Gardasil

On this page:

• What is Gardasil?
• Why is Gardasil needed?
• Is Gardasil safe?
• Why have questions been raised about the vaccine’s safety?
• Should these reports worry me?
• What non-serious problems have been reported?
• What are FDA and CDC doing about the concerns?
• How is Gardasil’s safety being monitored?

Recently, questions have been raised about the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) that cause most cases of cervical cancer and genital warts, and some vulvar and vaginal cancers.

What is Gardasil?

Gardasil is a vaccine for use in girls and women 9 through 26 years of age. It is approved for preventing cancer of the cervix, vulva and vagina, and for preventing genital warts caused by the types of HPV contained in the vaccine.

These four HPV types (6, 11, 16, and 18) cause about 70% of cervical cancers and about 90% of genital warts. They are also known to cause some vulvar and vaginal cancers. (Percentages related to these conditions are not well defined.)

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Why is Gardasil needed?

Gardasil may benefit the health of millions of people. Each year, more than 12,000 American women are diagnosed with cervical cancer, and almost 4,000 women die from this disease. In addition, about 6.2 million Americans become infected with genital HPV each year. Worldwide, cervical cancer is the second most common cancer in women, with 233,000 deaths per year.

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Is Gardasil safe?

Based on ongoing assessments of vaccine safety information, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to find that Gardasil is a safe and effective vaccine.

Studies involving approximately 21,000 girls and women in the United States and worldwide were conducted to evaluate the safety and effectiveness of Gardasil before the vaccine was approved by FDA. Approximately half of the study participants received Gardasil, and the other half received a control.

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Why have questions been raised about the vaccine’s safety?

There have been reports of serious adverse events in girls and women that have received the vaccine. These include death and Guillain-Barre Syndrome (GBS), a rare neurological disorder that causes muscle weakness.

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Should these reports worry me?

Based on the review and assessment of vaccine safety information available, FDA and CDC continue to find that the benefits of Gardasil outweigh the risks.

Twenty deaths had been reported to the FDA- and CDC-administered Vaccine Adverse Event Reporting System (VAERS) as of June 30, 2008, in women that received Gardasil.

However, no common pattern to these deaths has been detected that would suggest they were caused by the vaccine. In cases where autopsy, death certificate, and medical records were available, the cause of death was explained by factors other than the vaccine.

Given the large number of vaccine doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in a large population during the time period following vaccinations.

The manufacturer, Merck and Co., has distributed more than 16 million doses of Gardasil nationwide. As of June 30, there were 9,749 VAERS reports of adverse events following Gardasil vaccination. Of these, 94% were classified as reports of non-serious events.

Also, FDA routinely reviews manufacturing information, and has not identified any issues affecting the safety, purity, and potency of Gardasil.

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What non-serious problems have been reported?

• Syncope (Fainting)
• Pain at the injection site
• Headache
• Nausea
• Fever

Fainting, which may sometimes cause serious injuries from falling, is common after injections and vaccinations, especially in adolescents. FDA and CDC have reminded health care professionals that women receiving Gardasil should be watched carefully for 15 minutes after vaccination to avoid potential injury from a fall. The vaccine’s prescribing information includes this as well.

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What are FDA and CDC doing about the concerns?

FDA and CDC take all concerns about vaccine safety seriously, and, as they do with all licensed vaccines, will continue to closely monitor Gardasil’s safety.

Because available information indicates that Gardasil continues to be safe and effective, and that its benefits continue to outweigh its risks:

• CDC has not changed its recommendations for use of Gardasil.
• FDA has not made any changes to the Warnings or Precautions sections in the vaccine’s prescribing information related to safety.

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How is Gardasil’s safety being monitored?

• FDA and CDC closely monitor the safety of all vaccines through VAERS, which receives unconfirmed reports of possible side effects following the use of vaccines licensed in the United States.
• Each batch (known as a “lot”) of Gardasil is manufactured and tested for quality control according to the requirements of its FDA license. FDA verifies this, as it does with other vaccines, by performing a lot-by-lot batch review process.
• FDA’s review assures the appropriateness of manufacturing processes and confirmation of testing results. It also includes regular unannounced on-site inspections.
• No batch may be released for distribution until it has successfully completed all testing and review requirements.
• FDA analyzes possible side effects associated with individual lots to look for any unusual patterns.

CDC also has other systems in place to monitor the safety of all licensed vaccines.

This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

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For More Information

CDC and FDA Information on Gardasil’s Safety

www.fda.gov/cber/safety/gardasil071408.htm

Vaccine Adverse Event Reporting System (VAERS) Web site

www.vaers.hhs.gov

FDA Press Release (Sept. 12, 2008):

Approval of Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers

www.fda.gov/bbs/topics/NEWS/2008/NEW01885.html

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Date Posted: September 29, 2008

©2012 An Inconvenient Woman. All Rights Reserved.

What is FDA posting?

The following reports list any potential signals of serious risks/new safety information that were identified using the AERS database during the indicated quarter. The appearance of a drug on this list does not mean that FDA has concluded that the drug has this listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

FDA wants to emphasize that the listing of a drug and a potential signal of a serious risk/new safety information on this Web site does not mean that FDA is suggesting that healthcare providers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider.

FDA will complete its evaluation of each potential safety issue and may issue additional public communications as appropriate.

Why is FDA posting this information?

FDA is posting these reports in accordance with Title IX, Section 921 of the Food and Drug Administration Amendments Act of 2007 (FDAAA; see insert). FDA will publish a new list of potential signals of serious risks/new safety information identified each quarter.

How was the list generated?

FDA staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regularly examine the AERS database as part of routine safety monitoring. When a potential signal of a serious risk is identified from AERS data, it is entered as a safety issue into CDER’s Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) or into CBER’s Therapeutics and Blood Safety Branch Safety Signal Tracking (SST) system. Potential signals of serious risks are normally based upon groups of AERS reports, although a single AERS report could lead to further evaluation of a potential safety issue.

What information is provided?

The table in each report lists the names of products and potential safety issues that were entered into the above CDER or CBER tracking systems where the AERS database identified (or contributed to identification of) the potential safety issues.

A new report will be made available each quarter showing newly identified potential signals of serious risks/new safety information identified from the AERS database during the previous quarter. Information from previous quarters will remain available on the website.

Quarterly Reports

• January 2008 to March 2008

Back to Top Back to AERS

Date created: September 5, 2008

©2012 An Inconvenient Woman. All Rights Reserved.

By JARED A. FAVOLE

WSJ.com, September 5, 2008 8:07 p.m.

WASHINGTON — The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care professionals as early as possible.

The list includes a wide array of drugs, from Eli Lilly & Co.’s antidepressant Cymbalta to Purdue Pharma LP’s painkiller Oxycontin. It also addresses a range of adverse reactions, including cardiac arrest, cancer and Purple Glove Syndrome, which can result in patients having their arms amputated. (See the FDA’s list of drugs that are under investigation.)

The FDA has already sent out warnings about a handful of the drugs on the list. The report lists TNF blockers — such as Johnson & Johnson’s Remicade — as being potentially associated with cancer in children. In June, the FDA said it was investigating the possible link. TNF blockers target a compound known as tumor necrosis factor, which is overproduced in many patients with inflammatory diseases like arthritis and Crohn’s.

But there appear to be new ones, too. The report lists Biogen Idec Inc. and Elan Corp.’s multiple-sclerosis treatment Tysabri as potentially being associated with skin cancer. Medical journals have reported cases of melanoma in patients taking Tysabri, but the FDA hasn’t previously said it was investigating the drug for this side effect.

The list, which the FDA will start issuing quarterly, is aimed at giving consumers and health-care professionals early indications of what the FDA is investigating, but it might end up creating more confusion. Indeed, the agency is concerned “that people will stop taking a drug inappropriately” because it is on the list, said Paul Seligman, associate director of safety policy at the agency.

The FDA said it alerted companies whose drugs appeared on the list prior to it being made public — several companies said they received word late Thursday — and intends to give drug makers a heads-up in the future as well.

Drug makers said they support the FDA’s additional efforts to be transparent about drug safety, but some expressed concern that the information was being communicated to patients without context and wondered about what patients might do with the information.

“It is very, very important that patients and their physicians understand the benefits and the risks of the drug. To speak about one without the other could have an impact on patient perception of their medications,” said Tony Jewell, a spokesman for AstraZeneca PLC, whose psychiatric medication Seroquel made the list for the possible safety concern of overdose due to confusing sample-pack labeling.

Companies also cautioned that just because a drug is posted on the site doesn’t mean a causal relationship has been identified, and it is also risky if patients go off their medications without consulting a physician.

The FDA’s intention is for patients and doctors to use the list to be aware of potential adverse events and to encourage them to report any problems. The list doesn’t represent a comprehensive list of drugs the FDA is investigating, the FDA’s Mr. Seligman said.

The report is generated from the agency’s adverse-event-reporting database. That compilation consists of voluntary reports from patients and health-care professionals, and is widely considered to capture only a fraction of the actual adverse events associated with any given drug.

Mr. Seligman said the FDA is hopeful the quarterly reports will encourage people to report adverse events.

Write to Jared A. Favole at jared.favole@dowjones.com

©2012 An Inconvenient Woman. All Rights Reserved.