According to a study published this week in the New England Journal of Medicine, several major pharmaceuticals are withholding important details about clinical drug trials, despite urging from federal regulators and medical journal editors. The New England Journal of Medicine specifically cites Merck & Co., Pfizer, and Glaxo Smith Kline PLC as obscuring basic information in reporting on trials of drugs to treat serious or life-threatening diseases. Some of the drugs involved are already on the market.
For years, some drug companies kept secret the results of studies that reflected badly on their porducts and published only positive results. Critics say this helped mask safety problems. As the pharmaceutical companies continue to garner huge profits, it’s time for the federal government to provide proper oversight of these huge profit machines.
In documents filed in a Texas lawsuit against Guidant, the manufacturer of implantable defibrillators, the company failed to disclose publicly that Guidant officials had projected that some patients might die because of short circuits in their implantable defibrillator. According to the documents, Guidant did not disclose the information because the overall failure rate was not worthy of public disclosure. One might ask, “How many deaths warrant a ‘high enough failure rate’”?
The Food and Drug Administration released a warning letter yesterday it had sent ot Guidant Corporation restricting the ability of the company to win approval for some new medical products. The reason for the restriction stemmed from Guidant’s inability to fully respond to FDA concerns about manufacturing procedures at the company’s largest plant. The FDA cited a lack of proper controls, procedures, and methods to validate product improvements it was making. The warning letter dated December 22, raised eight specific deficiencies and threatened more severe penalties if Guidant didn’t properly fix the problems.
The FDA warning letter comes a week after documents were filed in a Texas lawsuit showed that Guidant officials had projected that some patients might die because of short circuits in one of the company’s implantable defibrillators. But the documents also suggest that the company did not deem the unit’s overall failure rate high enough to warrant public disclosure.
A recent inspection by the Florida Agriculture and Consumer Services Department found that many recalled defective products remain on stores’ shelves despite the fact that business owners could face fines of hundreds of thousands of dollars. Inspectors visited nearly 100 stores in 31 cities looking for several products which had been recalled and where supposed to be removed from stores.
About 10% of the stores in the random inspection offered for sale items which had been recalled. The range of threats posed by the recalled products ranged from mild to deadly. One of the products is a battery powered ride on vehicles (a children’s car ride) manfactured by Dorel Juvenile which poses a fire and burn hazard to its passengers.
The company (Dorel Juvenile Group ) has received nearly 50 reports of the vehicles overheating, smoking, and melting but says no serious injuries have been reported, according to a Chicago news website.
The FDA has ordered the withdrawal of the diagnostic imaging agent Neutro Spec after two reported deaths were associated with the product. Reports submitted to the FDA suggest NeutroSpec caused allergic reactions within minutes following administration. Those reactions led to the death of two patients and to cardiopulmonary failure, central nervous system problems and infusion reactions in other patients.
FDA officials emphasized all of the reactions occurred immediately after NeutroSpec was administered and there is no evidence that patients who already safely received the drug face any long-term risk.
NeutroSpec, approved for marketing in July 2004, is a diagnostic imaging agent that’s administered intravenously to help diagnose appendicitis in patients 5 years and older.
In May 2001, then Cardinal Ratzinger, Prefect for the Congregation of the Doctrine of the Faith (CDF) wrote a secret letter to all the world’s bishops re-asserting the legitimacy of the 1961 document Crimen Solicitationes which advocated keeping secret, among other things, sexual abuse by the clergy. In 2001, Ratzinger stated that the 1961 document is still in effect and should be the protocol for handling sexual abuse cases involving minors. The 2001 letter was necessary because in 1983 Pope John Paul II promulgated a new Code of Canon Law which superceded the 1961 letter as well as the old 1917 Code. The 2001 asserts once again that the proper purview for sex abuse cases is the Congregation for the Doctrine of the Faith and not civil authorities. In addition, Ratzinger states that such cases are bound by the “Pontifical secret” an arcane oath of secrecy which if broken is punished by excommunication latae sententiae.
In a letter dated May 18, 2001, then Cardinal Ratzinger sent a letter to all the bishops of the world reaffirming the Church’s operational secrecy concerning accusations of priestly sexual abuse. In the secret document, Ratzinger states that the proper forum for such cases is the Vatican. In demanding adherence to secrecy regarding sex abuse by priests, Ratzinger reminds the bishops that the penalty for disobedience to his directive is excommunication.
According to an article published in the Minneapolis-St. Paul Business Journal
Guidant heart devices have been linked to three new deaths. The information arose out of a Guidant report to the US Food and Drug Administration. The deaths occurred after Guidant had recalled the devices in June.
In an editorial published just hours ago, the New England Journal of Medicine blasts Merck for withholding key data regarding heart attacks caused by the use of their drug Vioxx. According to the statement released by the Journal, “we learned that relevant data on cardiovascular outcomes had been deleted from the VIGOR manuscript prior to its submission to the Journal and that the authors had withheld data on other relevant cardiovascular outcomes. The evidence has raised questions about the integrity of the data on adverse cardiovascular events in the article and about the article’s conclusions.
This recent development occurred as a result of plaintiffs’ lawyers deposing the executive editor of the Journal and subpoenaeing documents from Merck.
The New England Journal of Medicine posted an “expression of concern” that three heart attacks among patients who used Vioxx were left out of the date in a crucial Vioxx study called Vigor, making Vioxx appear safer than it actually was. In a statement released December 8, 2005 the New England Journal of Medicine said it became of the problem when plaintiffs’ attorneys subpoenaed a Journal Editor regarding the Vigor publication. Gregory D. Curfman, executive editor of the Journal was deposed on November 21, 2005. According to the New England Journal of Medicine Statement, the Journal learned that “relevant data on cardiovascular outcomes had been deleted from the Vigor manuscript prior to its submission to the Journal and that the authors had withheld data on other relevant cardiovascular outcomes. For the full stament from the New England Journal of Medicine go to: