Monthly Archives: March 2008

Vytorin and Zetia Shown to Be Ineffective Drugs

In an article published online by the New England Journal of Medicine, popular cholesterol drugs Vytorin and Zetia have not been proven to be effective in lowering the buildup of plaque, a leading cause of heart attacks and strokes. The Journal article recommends patients return to the older form of lowering cholesterol, namely, statins. However, it cautioned patients to consult with their physicians before discontinuing the use of Vytorin or Zetia.
The medicines, jointly sold by Merck & Co. and Schering-Plough Corp., were taken by more than 4 million patients in the U.S. last year and accounted for $5 billion in sales.
“What this tells us is that we have had far too many patients on these drugs than the science supports,” said Dr. W. Douglas Weaver, a cardiologist and president-elect of the American College of Cardiology. “I suspect we will see a significant decrease in prescriptions.”
Obviously, if the science doesn’t support it, the culprit is the marketing campaigns of these large drug companies. They push products without the scientific data to support their marketing claims. At times, they actually hide the scientific data so as to promote the drugs in question. Until the marketing practices of large pharmaceutical companies is regulated, this type of thing will become more commonplace.

Merck’s Singulair Probed for Potential Suicide Risk

As reports of suicidal thoughts, mood swings, and actual suicides became associated with Merck’s popular allergy and asthma drug Singulair, the FDA has decided to investigate if there is a causal relationship between the drug and suicide. Merck has updated the drug’s labeling four times in the past year to include information on a range of reported side effects: tremors, anxiousness, depression and suicidal behavior. The FDA has requested more data from Merck so that it may investigate the possibility of a causal relationship between the drug and suicide. The FDA began the probe after it received 3 or 4 suicide reports since last October.
Another popular drug, Chantix has been linked to mood disorders, suicidal thoughts, and suicides as well. Chantix is used by those who wish to quit smoking but has been found to have dangerous psychological side effects on those taking the drug and trying to quit smoking.

Sodium Phosphate Solution Linked to Kidney Failure

The oral sodium phosphate bowel preparation used in colonoscopies has been shown to cause kidney damage and long term renal failure, especially in elderly patients. Colonoscopy and flexible sigmoidoscopy are currently the most commonly used procedures for colon cancer screening and detection. Patients use a bowel cleansing agent the day prior to improve the diagnostic effectiveness of the procedure. Oral sodium phosphate solution (OSPS), oral sodium phosphate tablets (OSPT), and polyethylene glycol solutions (PEG) are the commonly used preparations because of their ease of use and their safety profile. Because an increasing number of patients are believed to have acute kidney injury from the use of OSPS and OSPT as bowel cleansing agents, the Food and Drug administration (FDA) issued a Black Box warning recommending that OSPS preparations should be used with caution in patients with impaired renal function. Case reports of acute renal failure in patients with presumably normal renal function are now being reported. Data suggests that elderly white women may be at increased risk. Whether this is true in the general population or is a selection bias based on the higher probability of this subset population undergoing screening colonoscopy procedures is unknown. There is a belief that in addition to causing AKI, OSPS and OSPT may also cause a chronic decline in renal function that might not be recognized and possibly not associated with OSPS or OSPT as causative agents.

Harvard Drug Study of FDA Deadlines Finds Increased Recalls

Recalled pharmaceutical drugs such as Vioxx, Bextra, Rezulin, and Baycol all were approved by the United States Food and Drug Administration (FDA) under speedy approval deadlines enacted in 1992 according to a Harvard study published in today’s New England Journal of Medicine. The New England Journal Article discusses the deadlines enacted in 1992 that required FDA approval of drugs within 12 months for most drugs submitted by pharmaceutical companies for sppedy approval and within 6 months for drugs designated as high priority for potentially life saving benefits. The speedy approval deadlines for most drugs was tightened to 10 months in 1997. Under the 1992 legislation the drug companies paid millions of dollars to the FDA for the speedy approval and the FDA was financially penalized if the drugs were not approved on schedule. This created a financial incentive for the FDA to approve a drug that might not be safe for the public in my opinion.
Harvard professor Daniel Carperter found that approval of drugs was 3.4 times more likely in the two months before the user fee deadline than at any other time. The study also found that drugs approved in the just before deadline time frame had a four to five fold rate of later being withdrawn or requiring additional later safety warnings.
This New England Journal article raises important public policy questions about the wisdom of the current FDA speedy approval rules that subject the FDA to financial penalties if it delays approval of a drug that may have a public health risk.

Kava Dangers Confirmed

While there are no restrictions on the sale and distribution of kava in the United States, there is mounting evidence that the herbal supplement should be banned due to damage it causes to the liver. Now, new scientific evidence reveals the severe liver damage associated with the ingestion of kava kava. Professor Iqbal Ramzan, Dean of Pharmacy at the University of Sydney Australia has published his findings in the January 28, 2008 edition of the World Journal of Gastroenterology. Dr. Ramzan spent one year studying the cellular effects of kava on the liver. The University of Sydney study focused on the major kavalactone (the ingredient in kava believed to affect the liver) — kavain — and investigated the effects it had on the ultrastructure (or biological structure) of the liver. The study found that following kavain treatment the liver tissue displayed an overall change in structure, including the narrowing of blood vessels, the constriction of blood vessel passages and the retraction of the cellular lining.
Interestingly, kavain also adversely affected certain cells which function in the destruction of foreign antigens (such as bacteria and viruses), which make up part of the body’s immune system.
In other words, the kavain treatment disturbed the basic structure of the liver, consequently seriously impacting the normal functioning of the liver.
The results of the University of Sydney’s study clearly support earlier literature observations on kava’s adverse affects on the functioning of the liver in general.

Ketek Probe Snares FDA Chief

In a stunning turn of events, the Congressional probe into Sanofi-Aventis’ drug Ketek has snared the head of the FDA, Andrew von Eschenbach, M.D. The FDA chief is now under investigation for perjury in light of his testimony concerning Ketek. The FDA approved Ketek in 2004 to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia. Soon thereafter, reports concerning liver damage began surfacing in those who used Ketek. During the Congressional probe of Ketek, the committee learned that Dr. Eschenbach’s testimony was not entirely truthful. Now, the FDA is stonewalling and refusing to hand over documents related to Eschenbach’s written testimony concerning the safety of Ketek and its subsequent approval. On February 12, 2008 the committee heard testimony from Douglas Loveland, a special agent at the FDA´s criminal-investigation office, told the committee that Aventis should have known there was fraud and there was a “catastrophic failure” of their clinical trial systems. They ignored “red flags” about the bogus data, “they were loud signals…they were bright signals.” Congressman Dingell responded by asking, “What is in those briefing books that he does not want either my Republican colleagues or our side to see? Is there evidence of perjury? Are there statements embarrassing to the administration?” He went on to say that “Neither Chairman Stupak nor I will tolerate such a perversion of Congressional powers to investigate and probe.” Dr. David Ross, the FDA’s chief examiner of Ketek was concerned about problems with Ketek and that the clinical trials contained information that was blatantly fraudulent. When he attempted to turn his findings over to the FDA advisory panel he was blocked.

Charges Dropped Against Chantix User

Andrew James Smith had been charged with disrupting a Thanksgiving flight forcing the aircraft to make an emergency landing in Fargo, North Dakota. However, the charges were dropped because the erratic behavior was linked to his use of the smoking cessation drug Chantix. Smith had no previous criminal history and prosecutors decided to drop the charges after learning the possible cause of his erratic behavior. The federal Food and Drug Administration issued a public advisory on Feb. 1, warning about a possible connection between Chantix and serious psychiatric problems. The FDA said it had received reports of 37 suicides and more than 400 reports of suicidal behavior in connection with the drug. Gerbasi, a Sacramento psychiatrist, examined Smith on Feb. 14, prosecutors said. “It is Dr. Gerbasi’s opinion, with reasonable medical certainty, that Mr. Smith, at the time of the alleged acts, had a diagnosis of Chantix-induced psychotic disorder, a severe mental disease,” prosecutors said in their motion to drop the charges.
“Mr. Smith’s behavior was extremely psychotic and disorganized,” the government motion said. “Mr. Smith verbalized delusional material that did not make sense and his actions were not goal-oriented.”

Botox Recall

Botox or botulinum toxin (available as Botox and Myoboloc) has been linked by the FDA to severe adverse reactions including respiratory problems and death in some cases. Adverse reactions can include paralysis of the respiratory muscles and difficulty swallowing (dysphagia), a condition that can allow food or liquid to enter the respiratory tract and lungs, causing aspiration pneumonia. FDA data found that the makers of the drugs had reported 180 U.S. cases of people developing serious conditions after receiving injections, including 16 deaths. While the FDA has warned about the dangers of Botox it fell short in that it didn’t require doctors and healthcare professionals to warn patients about these potentially lethal effects.

Zyprexa Lawsuit Settles

Eli Lilly, the manufacturer of the schizophrenia drug Zyrexa, has settled a lawsuit with the State of Alaska for $15 million. Alaska had sued Lilly in order to recoup costs associated with treating Medicaid patients who experienced weight gain and the onset of diabetes as a result of taking the drug Zyprexa. In his statement from the bench, Anchorage Superior Court Judge Mark Rindner, stated that as a result of the state’s lawsuit problems associated with bad drugs was addressed. This is an important statement in the light of higher courts’ decisions to side with big pharma and medical device companies in shielding themselves from accountability for harmful drugs and defective medical devices. The civil justice system provides an avenue for consumers to hold companies accountable for harmful products that cause injury. It also forces manufacturers to make better and safer products for consumers.

Cantaloupe Recall

Central American Produce, Inc. of Pompano Beach, FL announces a voluntary recall of cantaloupes grown, packed and shipped by an independent third-party grower, Agropecuaria Montelibano of San Lorenzo Valle, Honduras. The product was distributed nationwide and Canada. Based on current information, the cantaloupe grown, packed and shipped from Agropecuaria Montelibano appears to be associated with a Salmonella Litchfield outbreak in the United States and Canada.
In persons with poor health or weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections. Symptoms of food-borne Salmonella infection include nausea, vomiting, fever, diarrhea, and abdominal cramps. Individuals who have recently eaten cantaloupe and experienced any of these symptoms should contact their health care professional.