This is an excerpt from a story by CNN Fortune about long-term corruption inside Ranbaxy, a generic drugmaker. Ranbaxy makes, among other drugs, a generic form of Lipitor.
…Just three decades ago, generic drug companies in the U.S. were derided as patent breakers. They had no clear way to gain FDA approval, while brand-name-drug companies had a lock on the market. The 1984 Hatch-Waxman Act changed that. It created a pathway, the Abbreviated New Drug Application (ANDA), which allowed a generic drug company to simultaneously challenge a patent and demonstrate to the FDA that it could make a drug.
In the late 1980s several generic-drug companies were caught fabricating data and bribing FDA officials to gain approval. In the scandal’s wake, the FDA tightened regulations. It required that a company make three large “exhibit” batches to demonstrate that it could dramatically scale up its manufacturing, undergo inspection, and use an independent company to perform bioequivalence tests before an ANDA was approved. The purpose, says David Nelson, who exposed the 1980s scandal as a senior investigator for the House Energy and Commerce Committee, from which he retired in 2009, was to “prevent the systematic submission of false information” to get FDA approval.
The ANDA offered a lucrative reward for the company that risked almost certain litigation by first challenging a patent. If successful, the company got six months of exclusive sales after the patent lapsed, allowing the generics company to charge up to 80% of the brand-name price during that period. After that, other generics companies could jump in, and the price would drop to about 5% of the original price. Being first was the real jackpot. Consequently, first-to-file status became such an obsession that generic-drug company executives camped out in the FDA parking lot to file their paperwork first.
Ranbaxy learned how to game this system, according to former employees. To hasten the pace of its applications, Ranbaxy sometimes skipped a crucial intermediate step. Instead of making three medium-size exhibit batches and testing those for bioequivalence and stability, as required, Ranbaxy tested earlier and much smaller research-and-development batches that were easier to control and less costly to make. In some FDA applications, it represented these as much larger exhibit batches and presented the data as proof. And then there was the ultimate shortcut: using brand-name drugs as stand-ins for its own in bioequivalence studies.
These deceptions greatly accelerated the pace of the company’s FDA applications. They were also a grave public-health breach. Once Ranbaxy got FDA approval, it leaped straight into making commercial-size batches without any meaningful dry runs. The test results on file with the FDA were meaningless, and the drugs Ranbaxy was actually selling on the U.S. market were an unknown quantity, having never been comprehensively tested before.
To my readers in the greater Dallas area— are any of you interested in finding solutions to problems in health care, medicine, or public health?
I’d like to become involved with a local such think tank or create my own brain storm club.
I can’t watch this live because I have a lecture at the same time, but you should check it out—
Yale’s Institution for Social and Policy Studies presents The Future of Medicare: Policy Options and Political Realities. The discussion will be held on Tuesday, April 2, 2013, from 12:00-1:30 PM (E) and will be streamed live on YouTube.
Join us for a roundtable discussion that will address the fiscal realities of the Medicare program and examine the policy options and political challenges associated for making it sustainable.
David Brooks, Political and cultural commentator and Op-Ed columnist for The New York Times
Zack Cooper, Assistant Professor of Public Health and Economics, Yale University
Jacob Hacker, Stanley B. Resor Professor of Political Science and Director of ISPS, Yale University
Thomas Scully, Former Director of the Centers for Medicare and Medicaid Services (CMS) 2001-2003 under President George W. Bush
With Guest Moderator Sarah Kliff, Reporter for The Washington Post covering health policy
// blogmedreblogged via blogmed
reblogged via blogmed
Why this is the future, and why it is so important
While being able to monitor your own health would never eliminate the need for doctors, it could do wonders for everyone’s well-being. These cheap devices will keep track of your own health but, as I discussed with Scanadu’s founder, they can also be easily used to detect infection outbreaks at a national or planetary level, with people anonymously uploading data to a cloud. The Center for Disease Control or the World Health Organization can literally keep their fingers on the pulse of the entire planet. The possibilities are truly endless. No wonder Stephen Wolfram is one of their advisors. If they are successful, I can’t wait to see what people can do with all this anonymous data.
If these gadgets can really provide you with instantaneous feedback about your health status for such a low price, this will be the beginning of something much bigger. The monetary savings in prevention alone—and not depending on expensive laboratories for many tests—makes it all worthy.
But even more exciting is the potential increasing accuracy of diagnostics, based on the tracking of data over time. As Dr. Alan Greene, Chief Medical Officer at Scanadu, says:
When it comes to health, averages don’t cut it. Vitals change throughout the day and vary from person to person, so it makes no sense to assume we are all the same. Health decision shouldn’t be based on averages, they should be based on a real, accurate and personalized healthfeed of data, which we now have the power to give to the consumer in the palm of their hand.
Along with SCOUT, I saw two other products that were even more impressive: ScanaFlu and ScanaFlo. I couldn’t get photos of these—they are still in a rough prototype stage—but they are easy enough to visualize.
For ScanaFlo, imagine a disposable blue plastic rectangle with a QR code and a window that reveals paper swatches and a color calibration target (similar to this). To get a reading, you need to pee on the rectangle as one would on a pregnancy test. Depending on the content of your urine, the swatches will change color.
But what do these color mean? You don’t have to guess or remember. Point your smartphone at the QR target and it will take a photo, telling you if it detects anything out of the ordinary based on the hue of the paper swatches, which react differently depending on your health status. According its creators, ScanaFlo tests for “pregnancy complications, preeclampsia, gestational diabetes, kidney failure and urinary tract infections.”
ScanaFlu works in a similar way. Instead of a rectangle, it’s a square with a small protuberance on which you have to spit. Your saliva will be distributed to different test units using tiny nano-vessels. Incredibly enough, this “disposable cartridge will provide early detection for Strep A, Influenza A, Influenza B, Adenovirus and RSV.” Like ScanaFlo, you will use your phone’s camera to have a result sent to your app.
These disposable systems will be sold in packs, also at the end of 2013.
I shadowed a behavioral health masters student today in the hospital’s psychiatric department. I deliberately picked an area I knew next-to-nothing about because I want to keep an open mind for my future.
The student I shadowed intends to become a social worker. I was able to view a few rounds of group therapy (exercise, art, and discussion) and observe a psychosocial assessment of a new patient. It was very interesting— and I’m looking forward to the next round: next week, I will be able to attend the daily meeting between the doctors, nurses, and social workers re: patients.
Though I don’t necessarily want to become a psychiatrist, I do feel more certain that I want something that allows me to build a long relationship (and more complete history and evaluation) with my patients.
Also, it’s very easy for certain groups of people to be marginalized and treated as less-than-human. I was relieved to see quality people deliver quality care, especially because this is not always the case— both within and between institutions.