Time Magazine’s most recent investigation into the behavior of big pharma GlaxoSmithKline and their diabetes drug Avandia may have lead to further investigations by the FDA. Time’s investigation found that GSK officials weren’t entirely truthful when they told FDA officials that research on Avandia was inconclusive regarding an elevated risk of myocardial ischemic attacks. They revealed this five days before an article linking Avandia to a 43% increased risk of heart attacks compared to its competitors was to be published in 2007 by the New England Journal of Medicine. According to Time, “What GSK didn’t tell the FDA was that on May 14, 2007, two days before the White Oak meeting, GSK’s Global Safety Board had noted that a new assessment of Avandia studies “strengthens the [cardiac-risk] signal observed in the [previous] analysis.” Or that eight days earlier, the company’s head of research and development, Moncef Slaoui, had sent an e-mail to its chief medical officer saying Avandia patients showed an “increased risk of ischemic event ranging from 30% to 43%!” Or that the day before the meeting, the company had produced a preliminary draft report that showed patients on Avandia had a 46% greater likelihood of heart attack than those in a control group.”
This misdirection allowed GSK to continue to make huge profits at the expense of unsuspecting patients. Time estimates that the lack of full disclosure made the company billions in added revenue while putting millions at further risk of an increased risk of heart attacks.

The reaction to the soon to be dismissed lawsuit against the Vatican was very instructive as to how the Vatican and Church officials view the sex abuse crisis. Yesterday, we heard from the Vatican’s chief spokesman Fr. Federico Lombardi and the Vatican’s US lawyer Jeffrey Lena. We also heard from the Catholic League’s rabble rousing, pugnacious Bill Donohue. Interestingly, none of them feigned interest in the welfare of those who’ve been victimized by the sexual abuse of priests. Not one of them mentioned the human tragedy behind the lawsuits. Not one of these religious men seemed to care how their reaction would further hurt and alienate survivors of sexual abuse. Let’s take a look back and review what we heard from these men yesterday- Jeffrey Lena: the lawsuit always “lacked merit. The theory crafted by the plaintiffs’ lawyers six years ago misled the American public.” Fr. Lombardi called the voluntary dismissal of the lawsuit “good news”. How can the cover-up and secrecy surrounding child rape be termed “good news”? Finally, in a statement devoid of any grace or class, Catholic League bloviator released a statement which in part noted, “That’s right—once they got their check, they cashed out.” Donohue was referring to the survivors of sexual abuse. In another part of his remarks he refers to some abuse as “trivial”.
If the Bishops were smart, they’d distance themselves from Donohue and call for a public apology to the survivors of sexual abuse. Donohue, in his outlandish attempt at protecting the institution of the church, has boorishly stepped outside the bounds of propriety and decent behavior.

The last time I blogged about the for-profit fiasco that some call colleges, I’d mentioned the Wall St. Journal had published an opinion piece written by one of the school’s own top officials. I thought the self-serving piece was disturbing but not as disturbing as two articles published today about for-profit colleges. One story was in the Wall St. Journal (again) noting that the Post Co., the same one that owns both Newsweek and the Washington Post, had warned shareholders that it earnings may be affected by future Congressional inquiries into for-profit colleges. It just happens that the Post Co. owns Kaplan which is a large player in the for-profit college world. The other story came from the Huffington Post and related the sad story of a young woman who’d compiled $70,000 in debt pursuing a degree from the Art Institute of Ft. Lauderdale. According to the young woman, she succumbed to the school’s high pressure tactics, took out loans she couldn’t afford and received a degree that was worthless. Now, she’s stripping in Ft. Lauderdale.
These schools are backed by influential (Goldman-Sachs, Post Co.) corporations and have plenty of money. They are peddling their wares to overly eager young people searching for a way to obtain a degree. Finally, the government is getting involved after a GAO report noted fraudulent behavior on the part of 9 of the schools which it investigated.

After a Government Accountability Office (GAO) report found “deceptive practices” at the 15 for-profit colleges officials visited, Sen. Charles Grassley promised an investigation into the colleges and their accreditation process. The deceptive practices involved fraud concerning student loan applications. GAO officials, posing as prospective students, were encouraged to lie about family income, list fake dependents, and hide savings accounts. In some instances, prospective students were not allowed to speak with financial aid staff until they signed an enrollment agreement.
Curiously, the Wall St. Journal ran an Op-Ed piece a week or so before the NY Times published their story on the for-profit colleges. We’ve had former students of these for-profit colleges come to us seeking our advice after they’ve accumulated six figure debt without a degree or a degree that was accepted in Master’s or Doctoral programs.
If you’ve spent anytime at home during a weekday, you’ve seen the advertisements on television. The schools promise degrees in short periods of time that lead to rewarding careers. According to the NY Times’ story and our own experience dealing with the students, this is simply not true. Too often, these for-profit schools are run like a corporation rather than a higher educational institutions. In some instances, the schools are even properly accredited so the degrees they offer are useless and worthless.
Senator Grassley is correct in investigating this system. The last thing we want in this country is an educational system that’s based on duping unsuspected students with huge post-graduate debt, no education, and a worthless degree.

The FDA has been criticized in recent years for fast tracking approvals for medical devices that ultimately failed and had to be recalled or revised. In response to the criticism, the federal agency has issued a 120 page proposal outlining tougher rules for devices attempting to gain the FDA’s approval. The new proposals come after the FDA was critical of its own procedures after admitting to bowing to outside pressure from medical device companies to approve medical devices in a quicker fashion. The flash point revolves around the FDA’s controversial approval of ReGen Biologics Inc. (RGBO) knee device the prior year.
The new proposals are designed to deal with issues concerning the agency 510(k) application process. According to the Wall St. Journal, ” To access the 510(k) pathway, companies must show there is an already approved device similar to their new product; this was a big point of controversy in the ReGen case. The FDA, in its new proposal, recommended developing guidance to clarify when devices shouldn’t be used as a benchmark. The agency is still working on these definitions, and wants help from public comments, but pointed to evidence of confusion about the rules.
The FDA also wants to clarify its authority to rescind prior device approval, which has only been done about 100 times since 510(k) rules were created more than 30 years ago, officials noted.
Additionally, the agency proposed creating a subset of “Class II” devices, which are generally devices considered a moderate risk to patients, for which clinical or manufacturing data would be needed to bolster the case they are substantially equivalent to an already-approved product. Shuren said drug infusion pumps, which are ubiquitous hospital products the FDA is seeking to improve amid a history of problems, fall into this new “Class IIb” category.”

After reading a June 20th article in the NY Times concerning Zimmer Holdings Inc.’s relationship with two medical consultants, Senator Charles Grassley (R-IA) decided he needed to ask the medical device manufacturer a few questions himself.
The Times’ article had told the story of Dr. Dorr and Dr. Berger, two prominent orthopedic surgeons and one-time consultants to Zimmer regarding the artificial hips and knees. The Times detailed the doctors’ concerns about the orthopedic products. Dorr had warned other surgeons that the Zimmer Durom Cup was failing at an unacceptable rate. Berger complained to Zimmer about its knee device the NexGen CR-Flex which, according to Berger, was experiencing a high failure rate. In both instances, Zimmer told the surgeons that any failures should be attributed to improper technique rather than device failure.
Senator Grassley, perhaps recognizing such a dispute between a medical device company and surgeons places the patient in an untenable position, wants to know how Zimmer makes such a determination. Specifically, Grassley wants to know how Zimmer tracks the long-term effectiveness of their medical devices. (Most countries maintain databases with this information. The United States has no such system in place.) Additionally, Grassley wants a list of complaints consultants, including Dorr and Berger, have made to the company as well as information concerning Zimmer’s response to the complaints.
This is an important move by Senator Grassley. Anyone who read the Times’ article should have found the present stand-off between doctors and Zimmer disconcerting. Unless this is resolved, it’s the patients who lose.

I purposely waited to blog on this subject for a few weeks hoping Church officials might offer a coherent explanation of why it would bundle the issue of women’s ordination into the same document in which it announced new laws governing the sexual abuse of minors by Catholic priests.
The coherent explanation never came so I will speculate and offer my own thoughts on the subject. The document was published in order to discuss what the Church calls “delicta graviora” or the worst sins. While I would agree that the child sexual abuse by priests would clearly fall into that category, it’s hard to understand why the Church would consider women’s ordination a “delicta graviora”. The Vatican’s subsequent explanation doesn’t help matters. According to Msgr. Charles Scicluna, the priest in charge of punishing sexually abusive priests, “”There are two types of `delicta graviora’: those concerning the celebration of sacraments, and those concerning morals,” Scicluna told reporters at the Vatican. “The two types are essentially different, and their gravity is on different levels.”
The document has been received with a mixture of ridicule and ire. Some of the Catholic faithful are stunned by the move.
“Sometimes you wonder what they are thinking,” said Sister Christine Schenk, executive director of Cleveland-based group FutureChurch, which advocates for increased lay leadership in the Catholic Church.
“This is apples and oranges. The phenomenon of women wanting to serve God does not belong in same category as priests abusing children. I am frankly stunned.”
The portion of the document dealing with sexually abusive priests makes it easier for abusive priests to be removed from the priesthood. However, it neglects to deal with the larger, more important problem-the bishops who have transferred, covered up and lied for these priests. Anyone who has followed the Catholic priest scandal and the sex abuse crisis knows that there would be no scandal or crisis if the bishops hadn’t been complicit in their cover-up and cooperation with the abusers. This is the heart of the problem which remains unaddressed by the Vatican. The new laws don’t deal with the institutional, systemic problem of sexual abuse.
That’s why the civil justice system has played and continues to play a significant role in shaping public opinion and changing laws in order to protect children from further and future sexual abuse.

A week after an FDA advisory panel voted to allow Avandia to remain on the market, the same regulatory agency put a halt to a controversial study in which Avandia was compared to its chief rival Actos in terms of effectiveness in treating diabetes. The FDA ordered Avandia manufacturer GlaxoSmithKline to stop enrolling candidates for the study.
The Boston Globe reported that the Avandia study was halted because the FDA needed more time to study the risks associated with Avandia. This may strike some as odd since Avandia risks have been well documented since the 2007 Cleveland Clinic study first determined that Avandia was a risky drug that was not effective in treating diabetes.

In July 2008, Zimmer Holdings Inc., the manufacturer of the Zimmer Durom cup hip replacement device, suspended the product for what the FDA later called its “use/surgical technique instructions are inadequate”. Essentially, the Zimmer Durom cup hip replacement was recalled because the acetabular cup has shown signs of loosening and dislodging in a number of Zimmer hip clients. The Zimmer hip was designed so that the acetabular cup would allow for bony ingrowth which in turn would keep the cup component in place.
If you’ve had a Zimmer Durom hip replacement and have experienced pain, you should consult your surgeon. Some of the failed Zimmer hips have required revision surgeries in order for the loose hip component to be repaired or removed altogether.

The NY Times is reporting this morning that as early as 1999 GlaxoSmithKline were secretly trying to determine the safety and effectiveness of its blockbuster diabetes drug Avandia. In the spring of 1999, the pharmaceutical company ordered a secret study comparing Avandia with rival Actos made by Takeda. The results were not good. The study showed that Avandia was no better than Actos in treating diabetes. However, it did beat Actos in one category-it was much more dangerous for the heart.
According to the NY Times, GlaxoSmithKline spent the next 11 years trying to hide the results of these early tests. Rather informing the public of Avandia’s risks, the pharmaceutical company decided to bury the report and engage the public and the federal government in a massive cover-up. Funds that could’ve been spent on research and development to improve the poor-performing Avandia went instead to a PR campaign built on lies and obfuscation.
Today, the NY Times published an excerpt from one of the emails that discusses the cover-up, “Dr. Martin I. Freed, a SmithKline executive, wrote in an e-mail message dated March 29, 2001, about the study results that was obtained by The Times. “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK,” the corporate successor to SmithKline.
It would take another six years before the first public critique of Avandia saw the light of day. In the interim, thousands of unsuspecting doctors and diabetes patients took Avandia not knowing they were putting themselves at an increased risk of heart attacks.
Avandia Class Action Lawsuit