Monthly Archives: August 2010

More Disturbing News about For-Profit Colleges

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.

Congress Will Investigate For-Profit Colleges

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.

FDA May Move to Tighten Approval Process for Medical Devices

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.”

US Senator Wants Answers from Medical Device Company

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.