Wow, someone at HBR didn't get the memo that at Harvard you don't go after the establishment. Donald Light
writes at HBR (my bold):
Business executives may not know it, but they are wasting billions of their gross profits on ineffective, even harmful drugs in their health plans. That's one implication of the study Joel Lexchinand I just published in the BMJ (formerly British Medical Journal)...
The apparent business model of Big Pharma emphasizes the billions spent at great risk to find "innovative" and "breakthrough" new molecules that must be priced high to recover research costs that have become "unsustainable." However, revenues have increased six times more than their increased costs for research—hardly "unsustainable." This handsome return comes from the hidden business model that generates billions in costs for employers and employees.
The FDA approves new drugs as "safe" and "effective" with little evidence that they are either in regular medical practice. In fact, industry-friendly regulations prohibit the FDA from using comparative effectiveness to approve new drugs. That would be un-American because it would jeopardize "innovation" and high-tech research jobs. Of course, the opposite is true: requiring new drugs to be clinically superior would foster true innovation and stop rewarding pseudo-innovation.
Since companies test their own products—an obvious conflict of interest—they naturally design clinical trials to maximize evidence that they are beneficial and minimize evidence they are harmful. For example, they randomly sample from a pool that excludes people most likely to have adverse reactions, like patients with two or more health problems, women, children, and minorities. Many trials run for only a few months, long enough to gather evidence of a drug's main effects but too short to pick up evidence of many harmful reactions.
Then drug companies retain teams of science writers and editors to shape the published medical literature in order to persuade doctors that new drugs are more effective and safer than they are. Systematic reviews find that sponsored scientific articles almost always conclude the company's drug is better. Negative results are usually not published at all. Employees and their physicians thus get biased information about biased trials...
The bottom line is that prescription drugs have become the 4th leading cause of death and a leading cause of hospitalizations, accidents, and falls.
Light's spin on the truly horrific manipulations of Big Pharma appears to leave room for a call for a chnage in regulations, as though this will somehow do the trick to end the Big Pharma grip on drug introductions, but this clearly will not happen. The FDA is a power center that has been captured by Big Pharma. The only real solution is to shutdown the FDA and leave drug development and evaluation of drugs to the free market. This would remove the moat Big Pharma has put around drug development, which makes it near impossible for a small drug developer to get a drug approved at any reasonable cost. End the FDA, we have nothing to lose except early death!
Why wait for the FDA to be abolished? Why not do an end around by implementing an idea that I called medships. Park a used cruise ship off of the coast of the US, past the 12 mile limit, and establish a medical research and treatment center. No US federal, state, or local regulations would be applicable, thus, all issues involving the FDA's regulatory and approval processes would be moot.
ReplyDeleteI wrote about this in a series of blog posts. See http://thinkingmachineblog.wordpress.com/2012/08/03/why-we-need-medships/ and follow the links to the other posts.
Your solution is correct, his is not. There is no way to design a perfect testing system that people like this clamor for. You could test a drug for 50 years and never see a bad effect, because the bad effect didn't manifest itself until the 51st year. There is also no way to break the control pharma has over the FDA. As someone who is entering into this field in order to profit immensely from the absurdities of regulations surrounding clinical trials, I can tell you that the absolute best approach is the one you advocate for. Abolish the FDA. Let pharmaceuticals companies produce whatever they want, and they can be up front and open about their drugs. Consumers can choose what to use at their own risk, and if the pharma company was misleading or fraudulent it should be sued. Since that is unlikely to happen for a very long time (if ever) I intend to be a middle man and profit handsomely from our broken system.
ReplyDeleteI will never advocate for our current system, or advocate to increase regulations and government interference. But I will also not stand by idly and not profit from their mess, just because I find it morally repugnant.
In Michigan, thanks to past Republican control of the legislature and executive, lawsuits for product liability against drug makers are BANNED so long as the FDA approved the drug and the drug company did not defraud or buy off the FDA.
ReplyDelete(5) In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration's approval at the time the drug left the control of the manufacturer or seller. However, this subsection does not apply to a drug that is sold in the United States after the effective date of an order of the United States food and drug administration to remove the drug from the market or to withdraw its approval. This subsection does not apply if the defendant at any time before the event that allegedly caused the injury does any of the following:
(a) Intentionally withholds from or misrepresents to the United States food and drug administration information concerning the drug that is required to be submitted under the federal food, drug, and cosmetic act, … and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted.
(b) Makes an illegal payment to an official or employee of the United States food and drug administration for the purpose of securing or maintaining approval of the drug.
http://tinyurl.com/9aqgyrc
http://freepdfhosting.com/2d4fb617f6.pdf