Whistle-blowing Scientists (Trying To Prevent Dangerous Products From Reaching The Market) Sue FDA For Snooping On Their Personal Email Accounts

from the shameful-suppression dept

Last year, we wrote about the federal whistle-blowing act, which was designed to give protections to federal employees who blow the whistle on federal fraud and abuse. For reasons that still aren't clear, that bill was killed by a secret hold by either Senators Jon Kyl or Jeff Sessions. That fact only came out due to an amazing effort by the folks at On The Media, who kept hounding all 100 Senators to find out who would possibly kill such a bill. Recently, On The Media revisited the topic, noting that there was a new version of the bill. The report also talks about just how vindictive the government has been against whistleblowers. Even as President Obama has insisted that whistleblowers are important and should be protected, that's not what's happening in real life, with many getting stripped of their responsibility and demoted -- all for daring to point out waste, fraud and abuse. The worst example to date, remains the horrifying story of Thomas Drake, who was threatened with 35 years in jail in a bogus vindictive lawsuit against him, due to his blowing the whistle on a bogus NSA project.

More evidence of the insane lengths the federal government will go to against whistleblowers has been revealed in the form of a lawsuit from a group of FDA scientists and doctors. The group had been trying to blow the whistle on fraud and abuse in the FDA, in the form of approvals for medical devices that didn't actually meet health and safety standards. The scientists reached out to Congress to blow the whistle... and in response, the FDA started spying on their personal emails. Yes, it does appear that these scientists were accessing their personal Gmail accounts from work computers, and using them to work with Congressional staffers to craft their whistleblowing complaint, but does that give the FDA the right to spy on their personal communications? The doctors, via their lawsuit, believe the answer is no.

The FDA is defending its actions by claiming that this whistleblowing involved "improperly disclosed confidential business information about the devices," and it wanted an investigation of the doctors involved. That sounds ridiculous. Or, perhaps, all too typical. It seems clear that the FDA bosses just didn't like the fact that some folks there blew the whistle on what they were doing and took vindictive actions. This is exactly the kind of thing that a Whistle Blower Act should protect. That it doesn't do so already is really a shame.

Filed Under: email, fda, free speech, privacy, safety, whistleblowing

FDA's Pharma-First Focus Driving Medical Device Tech Away From The US

from the total-failure dept

Five years ago, we wrote about Andy Kessler's excellent book, The End of Medicine, a book I still think about frequently. Kessler's book explores why medical innovation hasn't followed the same innovation curve as every other technology space, where the technology gets better while the prices get cheaper. There are many reasons described in the book, but one key hurdle? The FDA. And it's not just the FDA's process, but the entire concept of the FDA, which is set up to approve or disapprove drugs. That's it. It's not designed to help review what will make people healthy. And for that reason, it pretty much ignores medical devices and technology. This was a big problem described in the book, and a few FDA folks in the book suggested the FDA was working on solving that issue. But it's been five years, and new reports suggest nothing much has changed.

Reason has an article about how the FDA is driving medical device innovation to Europe and elsewhere because it's still not set up to even think about medical devices. The article focuses on the new X-Prize attempt to create a "tricorder." It's a great contest, but then the article points to the news that the FDA won't certify such things:

The regulatory environment could present problems for any such device. "The Food and Drug Administration has stated that it will not certify tech that makes a diagnosis directly," said Ross Mitchell, the author of a study published last week that shows that strokes can be diagnosed with the aid of a smart-phone application with the same degree of accuracy as with a hospital computer.

Bartholomew says that because of FDA restrictions, the contest could lead to innovations that might only be used outside the United States.

Indeed, the report points to many other examples of useful new technologies showing up elsewhere, but not in the US due to the FDA. So why is the FDA so bad at actually helping people get healthy? Take a guess. It seems like regulatory capture has taken hold of the FDA in a big bad way. Just recently, we discussed how the FDA has set up a system to limit competition in the medical field to just a few giant pharma companies, and has been actively banning cheaper drug competitors, in order to help big pharma companies jack up the prices on old medicines.

While the FDA is supposed to be keeping us healthy, it looks like its general focus is on keeping the profits of a few pharma firms healthy instead.

Filed Under: fda, innovation, medical devices, patents, pharma

Is The FDA Helping Or Hindering Medical Innovation?

from the well,-that's-obvious... dept

Every time we talk about drug patents and the healthcare industry, without fail, someone shows up in the comments and makes the same simplistic claim: "you have no idea how much it costs to bring drugs to market!!!" Of course, that's arguing a slightly different issue, and it's important to break down what's being discussed. First of all, there's the question of how much does it really cost to bring medical innovation to market. There's a great book from a few years ago, called The $800 Million Pill, by Merrill Goozner, which debunks many of the claims about how much it really costs to bring a drug to market, which we noted recently has been updated in recent studies. What you realize is that (surprise, surprise) the pharma industry vastly exaggerates what it really takes to bring a drug to market. That's not to say it's cheap. It's not. But it may be an order of magnitude lower, and that makes a big difference. On top of that, a large percentage of the actual research budget comes from universities and is funded by the government anyway.

But... the defenders respond, the big expense isn't always research, it's clinical testing. And, in many cases that's true. Clinical testing is quite expensive. But why is it so expensive? That's another area worth exploring, and you begin to discover all sorts of issues that suggest this is a case where government regulation can often do more harm than good. David Levine points us to an excellent piece by Carl Schramm at Forbes pointing out how the ridiculous level of controls by the FDA aren't just making this process crazy expensive, but it's also limiting medical and healthcare innovation. And for what benefit? Obviously, the initial response many have to this is that the FDA and massive expensive clinical testing is necessary to protect people from dangerous drugs. But there are serious questions about how effective the FDA actually is in doing that. The clinical testing process often focuses too much on performance against a placebo, and not one whether or not people actually get healthier. On top of that, we've see that the FDA often seems to focus on helping pharmaceutical companies, rather than helping keep people healthy.

Schramm points out that the way to drive innovation is through "messy" capitalism, where lots more players get to test a lot more things -- the exact opposite of what the expensive FDA process entails. And while the obvious retort is that this will create much more dangerous drugs, it's not clear that's necessarily the case:

In any industry within a free-market society, the innovative process works best when it is allowed to be "messy." Lots of people are constantly trying new things, starting new companies and subjecting them to the test of the marketplace. From the cauldron of this market testing a higher order emerges, and the march of progress ensues.

And so it was in the early days of the pharmaceutical industry. Before FDA control, which took hold in the years after the Pure Food and Drug Act of 1906, the market was largely without barriers. A pharmacist might bring forth Bromo-Seltzer, or Noxzema, or Coca-Cola, or little liver pills or laudanum. Market forces would then determine if the product had value. Only tort liability acted as a check on the manufacturer, and, interestingly, there were few lawsuits.

Although extravagant claims were often made for "patent" medicines, the consumer was presumed to have common sense and to undertake some risk in all things. It was also presumed that manufacturers would follow high standards if they wished to stay in business, and indeed many firms and products from that era are still with us today. The Smith Brothers were trusted to make cough drops in a clean factory with good ingredients. Johnson & Johnson became a trusted name -- as did Eli Lilly.

Again, there are obvious problems with the way things were done a century ago. It doesn't mean we need to go back to that entirely, but at some point it should be realized that perhaps we're losing out on the cost side of the cost-benefit equation. Obviously, those making medical products have every incentive to have those products actually work. Rather than saddling them with massive clinical testing regimes, why not focus on transparency, that would provide more data and opportunities for everyone to properly evaluate the effectiveness and risks of certain products? As it stands now, the data from most clinical trials is totally hidden away. Imagine a much more open process that would allow people to access the data, share their own data and determine what really is and is not safe.

Andy Kessler's excellent book The End of Medicine does a nice job highlighting how the FDA's process is also so focused on drugs rather than actually making people healthy that it has created massive stifling effects on non-pharma medical advances. The book highlights all sorts of technological health care advances that could bring the same sort of computer/technology revolution to healthcare (making things faster and cheaper at an exponential rate), but so much of it is stifled by the FDA clinical trial process, meaning all sorts of useful products never actually make it to market.

And while I'm sure I'll face accusations of this in the comments, I am not saying that we should just wipe out the whole FDA process. I'm just suggesting that perhaps it's time to rethink how it works and what the real costs and benefits are... and if there might be a better way that is cheaper and actually encourages much more medical innovation.

Filed Under: clinical trials, fda, medical innovation

FDA, KV Pharma Bend A Bit To Public Pressure; Lower Makena Costs, Allow Competing Drugs To Remain... For Now

from the public-pressure-works dept

We've been discussing how the FDA has been systematically banning drugs that have been on the market for years, and retroactively granting monopolies to particular pharmaceutical firms. The case that's drawn the most attention is that of Makena, a drug to prevent early childbirth which is provided on the market by a bunch of different firms, and was competitively priced around $10/dose. Yet, after the FDA stepped in and gave a monopoly to KV Pharmaceutical under the economically-clueless belief that this would help make the drug "more available," there was a massive public backlash when people discovered KV would increase the price of the drug from $10 to $1,500.

In response, it appears the FDA is backing down ever so slightly. Drew points us to the news that it has put out a statement that it will not stop other pharmacies from making and offering the drug. KV had been threatening others, but the FDA stepped in and said that, even though it's granted this monopoly to KV, it wouldn't enforce it against these other manufacturers. The FDA put up a statement explaining this:

In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products.

Of course, it also says it may change its mind on this at any time (i.e., after the attention and backlash die down) and appears to have no interest in revisiting its other new monopolies.

Not surprisingly, with this news in place, KV Pharmaceutical has also announced that it is dropping the $1,500 price down to $690. Of course, that's still a lot more than $10 per dose, and this seems in response to the fact that (a) the public is blasting it at every turn and (b) the FDA won't really enforce the monopoly... for now.

How about we try to fix the underlying problem of monopolies, rather than just focusing on this one case?

Filed Under: drugs, fda, makena, monopolies, pharma
Companies: kv pharmaceutical

FDA Suddenly Bans Drugs That Have Been On The Market For Decades

from the perfect-gin-and-tonic-for-fun-and-profit dept

As Techdirt recently discussed, the drug pipeline is running dry, as Big Pharma's patents are beginning to expire, and the drug companies are freaking out. For years they have been spending more money on research and testing and getting fewer results. This year alone they are going to have 11 patents expire on drugs that bring in approximately $50 billion in revenue to the big pharma firms. Of course, the flip side to this is that consumers can start saving about 95% on the price of those drugs, as generics hit the market. The drug companies have gotten to a point where the incremental increases in efficiencies are so small as to be meaningless. What is coming is more personalized and targeted treatments for diseases -- treatments that do not require bulk production of a specific chemical, but individual testing and personalized care, and not lifetime treatments and repeat sales, but cures. The treatments will be expensive to begin with, but they will become less expensive over time. The business model of healthcare is about to change dramatically, and Big Pharma needs to do something to maintain their profits. Unfortunately, they seem to have chosen the path of regulating the competition out of existence, rather than competing and innovating.

One way the drug companies have been coping is to repackage and rebrand health food supplements. Drugs like Lovaza, which is nothing more than the fish oil you can get in health food stores, and lovastatin which has been in use for roughly a thousand years (800 AD) in the form of red yeast rice. In the case of lovastatin, the FDA banned the supplements because they are "identical to a drug and, thus, subject to regulation as a drug." That is very convenient for the drug company, which now charges monopoly rents on the product -- which can increase prices at ridiculous levels.

More recently, the FDA banned 500 prescription drugs that had been on the market and working for years. To be fair, it was really 50-100 drugs (pdf), made by different companies, but that just highlights how there was actual competition in the marketplace for these drugs, which has now been removed. For all of the drugs, there is either a high-priced prescription version, or all the small manufacturers have been removed, leaving a virtual monopoly for one or more larger companies. This process began in 2006 when the FDA decided to remove marketed unapproved drugs (pdf).

The reasoning is that these drugs weren't ever technically "approved" by the FDA. While the FDA has been around for about a century, the business of having the FDA first approve drugs before they could go on the market came about closer to fifty years ago, and a bunch of "unapproved drugs" that were in common usage before that never got approved. The FDA is targeting many of those, even if they have a long history in the marketplace. Conveniently, of course, there always seems to be a pharma company with a monopolized substitute ready.

In 2006 the first "new" monopoly that was created by this FDA process was for the malaria drug quinine sulfate. This left only Mutual Pharmaceutical Company to manufacture quinine in the US (pdf). While malaria is not a disease that affects many people in the US, it is big business worldwide. Malaria causes 300 to 500 million infections and over 1 million deaths each year. Treating this disease with quinine used to cost pennies a day. In fact, the British turned this treatment into a cocktail, the gin and tonic (quinine water).

Another drug removed was the antihistamine carbinoxamine, which was created prior to needing FDA approval, in the early 1950s. It was approved by the FDA in a slightly modified form in 2006. It is now sold exclusively by Mikart, Inc and Pamlab, LLC with no future competition because the FDA has banned all 120 other versions of carbinoxamine. You can imagine just how much that must increase the profits for Mikart and Pamlab on carbinoxamine, though that seems to come at the expense of consumers.

It's really nice being granted a government monopoly.

As for the drugs now being banned in this latest purge, you can argue that it's not really 500 drugs, because many are different combinations of the same 50 to 100 drugs. To be sold, these disapproved drugs will require drug trials and certification -- a massive and expensive process. Under current law, after successful completion of FDA trials these drugs will be granted approval. But in every case these trials are almost certainly not necessary. And, "coincidentally" in almost every case, there is a chemically similar patented version ready to go. This is a pure money grab: replacing old tried and true drugs, with monopoly priced prescription drugs. It just requires removing competing drugs from the market to increase profits.

And with that, I'm off to go have a gin and tonic, while it's still legal...

Filed Under: drugs, fda, health care, monopolies

As The FTC Goes After Bloggers, Doctors Making Millions Promoting Drugs With Little Oversight

from the feeling-healthy-yet? dept

Clay Shirky points us to a column from a few months back by Marcia Angell, which explains why clinical research on drugs isn't even remotely trustworthy, as it all-too-often seems to involve doctors who have serious conflicts:

Or consider Dr. Alan F. Schatzberg, chair of Stanford's psychiatry department and president-elect of the American Psychiatric Association. Senator Grassley found that Schatzberg controlled more than $6 million worth of stock in Corcept Therapeutics, a company he cofounded that is testing mifepristone--the abortion drug otherwise known as RU-486--as a treatment for psychotic depression. At the same time, Schatzberg was the principal investigator on a National Institute of Mental Health grant that included research on mifepristone for this use and he was coauthor of three papers on the subject.

Angell notes that this is pretty common:

Indeed, most doctors take money or gifts from drug companies in one way or another. Many are paid consultants, speakers at company-sponsored meetings, ghost-authors of papers written by drug companies or their agents, and ostensible "researchers" whose contribution often consists merely of putting their patients on a drug and transmitting some token information to the company.

And as the relationship between doctors and pharma has gotten deeper and deeper, it means that the results of those all important "clinical trials" -- which the pharma supporters always insist are so important -- are highly suspect:

Because drug companies insist as a condition of providing funding that they be intimately involved in all aspects of the research they sponsor, they can easily introduce bias in order to make their drugs look better and safer than they are. Before the 1980s, they generally gave faculty investigators total responsibility for the conduct of the work, but now company employees or their agents often design the studies, perform the analysis, write the papers, and decide whether and in what form to publish the results. Sometimes the medical faculty who serve as investigators are little more than hired hands, supplying patients and collecting data according to instructions from the company.

In view of this control and the conflicts of interest that permeate the enterprise, it is not surprising that industry-sponsored trials published in medical journals consistently favor sponsors' drugs--largely because negative results are not published, positive results are repeatedly published in slightly different forms, and a positive spin is put on even negative results. A review of seventy-four clinical trials of antidepressants, for example, found that thirty-seven of thirty-eight positive studies were published. But of the thirty-six negative studies, thirty-three were either not published or published in a form that conveyed a positive outcome. It is not unusual for a published paper to shift the focus from the drug's intended effect to a secondary effect that seems more favorable.

And yet the FTC is more worried about a mommy blogger recommending a book that a publisher sent her for free?

Filed Under: conflicts, doctors, drugs, fda, ftc