April 15, 2008
Medical News Today: GlaxoSmithKline Confirms Receipt Of FDA Letter On Regulatory Reporting
The US Food and Drug Administration (FDA) sent a warning letter to GlaxoSmithKline related to reporting requirements for approved medicines. The FDA inspected GSK's reporting processes conducted last year, specifically, in relation to Avandia. There were omissions from periodic reports to the FDA, such as summaries of final data from some clinical trials and the start and progress of the clinical trials. GSK initiated a review of processes and reporting systems after the inspection.

April 14, 2008
Royal Society of Chemistry: Psychiatric drug ads 'frequently misleading'
Claims made in psychiatric drug advertisements, including ads for antidepressants, are often misleading and impossible to verify, according to a new study by Chemistry World. When the team, which included psychologist Glen Spielmans of Metropolitan State University, analyzed the advertisements, they found over 35% of the claims were not supported by their cited sources. This included the New England Journal of Medicine.

Researchers also found that nearly 80% of the ads made at least one claim that was not supported by the data source. GlaxoSmithKline, Pfizer, Shire and AstraZeneca did not reply to the researchers. Wyeth refused to send their trial data. Antidepressant sales are close to $13.5 billion in US sales and $20.6 billion worldwide in 2006. Spielmans claims that 21 Food and Drug Administration officials at the agency's Division of Drug Marketing, Advertising and Communications were charged with reviewing over 39,000 ads aimed at doctors in 2005.

"When I saw how many ads they have to review, it's mind boggling," said Spielmans. Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America said, "Federal safeguards are in place to help assure that the advertising and promotional material disseminated by America's pharmaceutical research companies in US publications is accurate and well substantiated."

April 14, 2008
In-PharmaTechnologist.com: Heparin death tally worsens; FDA issues device warning
Deaths from allergic/hypotensive symptoms after using heparin has shot up from 19 to 62. Forty seven of these deaths were reported when the first evidence of heparin contamination was discovered. Recalls were issued. The U.S. Food and Drug Administration (FDA) has sent a letter to drug device manufacturers warning them to examine the sources of heparin used in their products. The recalled heparin which is normally derived from pig's intestines was contaminated with oversulfated chondroitin sulphate, which is made from animal cartilage and a less expensive alternative. Nineteen of the 62 deaths have been linked to Baxter's heparin, however, Baxter states that only four deaths have been linked. The FDA is still investigating how the heparin was contaminated in the supply chain in China.

March 31, 2008
Health Law 360: FDA Demands Safety Plans For 25 Drugs, Biologics
Twenty five medications and biologics has been targeted by the U.S. Food and Drug Administration as posing risky side effects. The FDA has directed the manufacturers to prepare safety plans to ensure they are prescribed properly. The drugs include the acne medication, Accutane and two chemotherapy medications, Thalomid and Revlimid. A medication guide, patient package insert, elements to assure safe use, a communication plan and an implementation plan will all have to be included in the safety plan. The deadline is September 21, 2008. If the manufacturers miss this deadline, the FDA can choose to impose civil penalties.

March 31, 2008
Daily News: Study makes doctors wary of new cholesterol drugs Vytorin and Zetia
A panel of four cardiologists told an audience of over 5,000 at a major cardiology conference that the medications Vytorin and Zetia may not work to lower cholesterol and the drugs should only be prescribed as a last resort. Statins, which are older cholesterol lowering drugs, have proven benefits and are probably less expensive and should be relied on more heavily. Lipitor and Zocor are also statins. The manufacturers of Vytorin and Zetia, Merck and Schering-Plough, disagree with the recommendations and state they are valuable treatments for patients. Preliminary results that were disclosed in January were also discussed at the conference and prescriptions for Vytorin and Zetia have dropped about 15% since January.

March 17, 2008
The New York Times: Tainted Drugs Put Focus on the F.D.A.
The Food and Drug Administration (FDA) has admitted that it violated its own policies by failing to inspect the Chinese plant that has been linked to as many as 17 deaths in the United States after contaminated Heparin was imported. William Hubbard, a former FDA deputy commissioner, said "This heparin problem has happened before with other drugs and it's going to keep happening until Congress fixes the problem." The amount of drugs coming from China has soared, while the FDA's inspections of overseas drug plants has dropped. There are at least 566 plants in China that export drugs to the United States, but only 13 were inspected by the FDA last year. The Bush Administration has no plans to fix the most basic of problems, which is the money to inspect more plants. However, the Senate passed a budget resolution on March 14, 2008 to allocate an additional $375 million. Julie Zawisza, an FDA spokeswoman said, "The agency is opening an office in China to conduct audits and inspections." Eighty percent of the ingredients in drugs consumed in the United States are manufactured abroad, with 40% being made in China and India.

March 4, 2008
NewsInferno.com: FDA to Review Safety Notification Procedures
The Food and Drug Administration (FDA) has been criticized for not doing a thorough job protecting Americans from unsafe drugs. They are now reviewing their safety notification process regarding prescription drugs, medical devices, foods and other products it regulates. Warnings are issued by the FDA about defective medical devices, drug side effects and recalls of tainted food. The agency often issues press releases to the media or it releases statements on its web site. Representative Bart Stupak 's 17 year old son, committed suicide while using Accutane. Stupak said, "If Americans knew how little the FDA does to assure the food and drug supply, if the truth ever came out, people would be marching in the street." Stupak is an eight term Democratic congressman and chairman of the Subcommittee on Oversight and Investigations of the House's Energy and Commerce panel. The panel has jurisdiction over the FDA. The subcommittee is investigating the FDA's handling of Heparin, manufactured by Baxter International, Lipitor, manufactured by Pfizer, Vytorin, manufactured by Schering-Plough and Merck. Anemia drugs sold by Amgen and Johnson & Johnson are also under review.

February 26, 2008
Financial Times: Study casts doubt on anti-depressants
Psychologists from the University of Hull, located in the UK, reviewed approximately 50 antidepressant clinical trials. They found that antidepressants worked no better than placebo in mildly depressed patients. Even trials that suggested some benefit to severely depressed patients wasn’t very great. Researchers focused on four of the widely prescribed antidepressants, including Prozac, Effexor and Paxil (Seroxat). Mind, a mental health charity, is urging General Practitioners to consider alternative therapies, for example, exercise, outdoor exercise especially, since it believes it has shown to be very effective in fighting depression.

February 1, 2008
Fox News: FDA: Epilepsy Drugs May Increase Risk of Suicidal Thoughts
A Food and Drug Administration (FDA) investigation started in 2005 has found that people taking epilespy drugs are at higher risk of committing suicide than those taking a sugar pill.  The FDA analyzed approximately 200 studies of 11 anti-seizure medications.  Medications were given to almost 28,000 people and another 16,000 were given placebo medications.  Drug treated patients who experienced suicidal thoughts or behavior was .43%, compared with .22% of patients given a placebo.  Four people in the drug treated groups committed suicide while none did in the placebo groups. Drug treated patients were at twice the risk of experiencing suicidal thoughts whether or not they actually suffered from epilepsy, however, per the FDA, the risk is highest for epilepsy sufferers.  The FDA analyzed data from 11 well-known anti-seizure drugs including Pfizer's Neurontin, Novartis AG's Tegretol and Abbott Laboratories' Depakote.  The FDA said it expected the risk applies to every epilepsy drug and will work with manufacturers to add the warning to product labels.

January 31, 2008
The Wall Street Journal: Article on Avandia Study Was Leaked to Glaxo
Steven Haffner, an internal medicine professor at the University of Texas Health Science Center in San Antonio, broke confidentiality rules and faxed a copy of the article he was peer-reviewing last year for The New England Journal of Medicine (NEJM) regarding Avandia and the risk of heart attacks, to an employee of GlaxoSmithKline.  Haffner knew the employee from working with him on an earlier clinical trial of the drug.  He faxed the article which he reviewed 17 days before it was to be published.  The NEJM published the article on May 21, 2007 which led to a sharp drop in Glaxo's stock and plunging sales of Avandia.  Dr. Haffner states, "Why I sent it is a mystery.  I don't really understand it.  I wasn't feeling well.  It was a bad judgment."  Haffner has financial ties to Glaxo, which includes getting paid for giving speeches for the company.  Per FDA documents, Glaxo has paid him approximately $75,000 in consulting fees and speaking engagements since 1999.   

The NEJM considers the peer-review process as confidential and deals with any breach of ethics privately.  Glaxo did not inform the NEJM that they had a copy of the study but have since confirmed that they received a copy and that Haffner wanted Glaxo to provide input.  Ms. Pekarek, Glaxo's spokeswoman, confirmed that Haffner had sent a copy to the employee and that no senior Glaxo executives traded stock based on the advance notice of the publication.  Medical journals do not give drug companies advance copies of papers concerning their drugs.

January 24, 2008
New York Times: F.D.A. Requiring Suicide Studies in Drug Trials
The Food and Drug Administration (FDA) is now requiring drug companies to look for suicidality as an adverse event during clinical trials.  Companies who make drugs for the treatment of obesity, urinary problems, epilepsy, cessation of smoking, depression and many other conditions are now, for the first time, being asked by the FDA to put a comprehensive suicide assessment into their clinical trials using a new questionnaire called the Columbia Suicide Severity Rating Scale.  FDA officials admit that since suicidal events emerged in pediatric antidepressant data, which now carry a black-box warning, that they should look for this event in other drug trials.

When French drug-maker Sanofi-Aventis applied for an application for the obesity drug, Rimonabant, researchers discovered the drug could cause psychiatric problems.  Also, this month, the results of a trial of Taranabant, also an obesity drug made by Merck, were published and showed similar psychiatric problems.  Acne, hypertension, high cholesterol, swelling, heartburn, pain, bacterial infections and insomnia drugs can all cause psychiatric problems.  Many companies and academic research programs have adopted the new questionnaire, which has been translated into 80 different languages.

January 21, 2008
Newsday.com: List of problem prescription drugs is growing
More than 40% of the U.S. population is taking at least one prescription medication.  The growing list of medication concerns is alarming consumer watchdogs and drawing public attention.  Research this month raised concerns regarding the effectiveness of Vytorin over other cholesterol lowering medicine and now a congressional investigation is underway into Schering-Plough and Merck's questionable advertising of the drug. Antidepressants took another hit when a recent analysis was published in the New England Journal of Medicine  suggesting doctors and patients may have been misled about the effectiveness of antidepressants.  During the summer of 2007, studies revealed heart failure risks associated with  the diabetes drugs,  Avandia and Actos. Now, both drugs carry a black box warning.  Patients often learn about problems with medications inadvertently and discover them sometimes before their doctors.  Eric Heifetz was prescribed Vytorin and learned via media about the negative study before his doctor did.  His doctor switched him to Lipitor.

January 17, 2008
Antidepressants, Lack of Efficacy Finally Exposed
The effectiveness of a dozen popular antidepressants has been exaggerated by drug manufacturers and therefore misleading doctors and consumers, according to a new study published in the New England Journal of Medicine.

December 16, 2008
DiabetesHealth: Doctors Say Avandia Warning Label Should Tout Vegan Diet
The Physicians Committee for Responsible Medicine has petitioned the Food and Drug Administration (FDA) to require that Avandia's warning label include a statement that a low-fat vegan diet is safer and a more effective approach to lowering blood sugar levels than the drug itself.  The group's request comes after a recent FDA decision to require a "black box" warning on Avandia warning users to the increased risk of heart attacks.  The committee says the benefits of the diet, which include lowering of blood pressure and cholesterol levels and weight loss, as well as the prevention of heart disease, should be made clear to Avandia users.

December 20, 2007
WDDTY: Avandia: New study confirms it’s a high-risk drug
A new study published from the University of Toronto confirms that Avandia can dramatically increase the risk of congestive heart failure and fatal heart attack.  The study covered health profiles of 159,026 patients who were given the drug or a different one to treat Type II Diabetes.  Nineteen per cent, or 30,265 died from congestive heart failure while 7.9% also had congestive heart failure and survived with a similar number having heart attacks.

December 6, 2007
Medline Plus: Diabetes Drug Avandia Could Weaken Bones
Long time use of Avandia may contribute to bone loss, speeding of osteoporosis and thinning of the bones leading to fatal and/or dangerous fractures.  The study was conducted by the Salk Institute for Biological Studies in La Jolla, California.  There are over 3.5 million U.S. patients taking Avandia.

November 20, 2007
FDA News: Senate Report Alleges GSK Intimidation Over Avandia Concerns
GlaxoSmithKline (GSK) tried to intimidate and silence university professor John Buse after he raised concerns on Avandia and cardiovascular events.  Buse spoke about the intimidation at a House Oversight and Government Reform Committee hearing, and stated that at one point a company employee of GlaxoSmithKline told him that he could be held liable for a $4 billion drop in the company's stock.  GlaxoSmithKline, per Buse, then composed a letter for him to sign that stated he was no longer worried about the increased risk.  Max Baucus, Senate Finance Committee Chairman, and Chuck Grassley, Ranking Member, sent letters to GSK and the University of North Carolina asking for contacts, documents and communications between the organizations related to Avandia (rosiglitazone maleate).  It was found that high ranking executives, including CEO Jean-Pierre Garnier, were involved in discussions to silence Buse.

November 19, 2007
Canada.com: Painkillers, antidepressants a risky combination
According to a report in the October issue of Alimentary Pharmacology and Therapeutics, anyone taking an SSRI-antidepressant such as Paxil, Prozac or Zoloft and also taking a nonsteroidal anti-inflammatory drug (NSAID), such as Motrin, Aspirin or Celebrex, should be aware that this combination of drugs can cause an adverse reaction and increase the risk of upper gastrointestinal bleeding.  Physicians should carefully review their patients' charts.  Patients should keep an eye out for any unusual bleeding. 

November 16, 2007
Chicago Tribune: FDA toughens label warning on Avandia
Short of recalling the drug, the Food and Drug Administration has placed a black box warning, the agency's strongest warning, on the diabetes drug Avandia stating the drug could cause chest pains or heart attacks.  GlaxoSmithKline will conduct a study comparing Avandia and another popular diabetes drug, Actos, manufactured by Takeda beginning next year. The study will be completed by 2014, but the Food and Drug Administration will be reviewing data as the study progresses.  Avandia has been under scrutiny since an analysis last May linked it to a 43% higher risk of heart attack in patients.

November 9, 2007
Wall Street Journal: Merck's Tactics Largely Vindicated As It Reaches Big Vioxx Settlement
Merck and Company has agreed to pay out $4.85 billion to settle thousands of lawsuits over their arthritis painkiller Vioxx. The company faced approximately 26,600 lawsuits representing 47,000 plaintiffs and in addition, 265 potential class action cases, making it one of the largest civil cases ever.  The agreement will affect cases filed in federal and state courts.  Payments will vary, depending on injuries and the length of time Vioxx was used. Under the settlement plan, plaintiffs will have to show that Vioxx was taken for at least 30 days, and must have suffered a heart attack or ischemic stroke within 14 days of using the drug. Merck, headquartered in Whitehouse Station, New Jersey, is still facing a number of government investigations at both state and federal levels.

November 7, 2007
LawyersAndSettlements.com: Avandia Second Black Box Warning Urged
GlaxoSmithKline (GSK) introduced Avandia as a treatment for Type II Diabetes in 1999.  It came under attack when a prominent cardiologist went public that it had the potential for serious problems with the heart.  GSK downplayed the risks.  It has been a back and forth battle ever since.  In August 2007, the Federal Drug Administration announced that Avandia would have a black box warning with regard to increased risk for heart failure.  The Federal Drug Administration is now pushing for a second black box warning in regard to the increased risk of heart attacks.  A black box warning is the strongest warning the Federal Drug Administration can impose. 

October 24, 2007
Yahoo News: FDA eyes new boxed warning on Glaxo's Avandia: WSJ
The FDA (Food and Drug Administration) is pushing GlaxoSmithKline to place a black box warning on their diabetes drug, Avandia.  The warning will be for the risk of heart attacks.  Last year, global sales of Avandia were $3.24 billion.  Sales have plummeted this year since a study in May links Avandia to an increased risk of heart failure. 

October 18, 2007
New York Times: V.A. Is Limiting Use of Diabetes Drug
The Department of Veterans Affairs issued 1,389,497 Avandia prescriptions for 161,096 patients from September 2006 to August 2007.  They conducted their own review of GlaxoSmithKline's drug, also known generically as rosiglitazone, and decided to remove it from their formulary on October 5, 2007.  The decision came after the department's conclusion that for some patients, Avandia did not have the same safety margin as other possible treatments. Eight percent of Avandia's sales are contributed to the Veterans Affairs.  The FDA is still reviewing Avandia's safety since the New England Journal of Medicine published an analysis suggesting Avandia increases the risk of heart attack by more than 40 percent.

Sept. 24, 2007
Bloomberg.com: Glaxo's Avandia Increases Bone-Fracture Risk, Study Confirms
According to a company funded study by GlaxoSmithKline, Avandia increases the risk of bone fractures in women who take it.  The bone fracture injuries first were linked several weeks ago when Baskent University in Andara completed a study.  Medical journal reports this year have stated that Avandia increases the risk of heart attacks by more than 40%.