The wsj starts off with a good review on Thalidomide, but later cannot help itself...

 

Any sensible person who reads the wsj knows the publication is a double-edged sword at best. You mostly read it for the financial news and hope they are not lying through their teeth. And, like diamonds in the rough, or other undesirable places, every now and then, they do manage to write about things in a meaningful manner. 

It was with this sort of pleasant surprise that I started to read a review of the book titled "Frances Oldham Kelsey, the FDA, and the Battle Against Thalidomide". It is a poorly kept secret that the FDA was provided with ammunition at the most opportune of times, with which it prevented much death and dismemberment. It is also well-known that in today's political environment, such powers would be quite tough to come by, as this article linked below will demonstrate. 

The earlier part of the review

The earlier part of the review is pretty cool. Thalidomide, prescribed as a sleep aid, would have escaped review were it not for Frances Oldham-Kelsey's keen scientific eye and healthy apprehension for something that appeared too good to be true. Having worked on a drug that had a deleterious effect on fetii, she stepped up at the right time and required William S. Merrell Pharmaceuticals to provide more data. The ensuing saga, even in the short review, reads like a B-movie plot, and I leave all that up to you. I definitely recommend the review, and I personally put the book on my list of must-reads. 

The ignorant whiny part

Just when I was about to fool myself into thinking, "Wow, the wsj is about to become the WSJ in my eyes!", the review slipped into the well-branded, stereotypical, tone deaf part: "Ms. Warsh fails to discuss the tradeoffs of the glacial approval process"

You know what the tradeoff is? STAYING ALIVE and HEALTHY. It is remarkable that in the same review about a book that shows how one scientist stood in the way of unknown thousands of mutilated fetii and a good drug review process and created a revolution that now the world has started to embrace (with the EU pulling ahead of us), the review author irresponsibly caters to wsj's baser instincts. 

Conclusion: How to do approvals right

Drug and device approvals are quite tough to get right, even when the FDA is acting ethically, and not colluding with surgical supplies companies (I will link a post in which I touch upon the bad governance below), things slip by. Thus we end up with bad metal implants, knees, hips, you name it, questionable Azheimer's drugs and much more. 

Then, as with Aduhelm, (story below), the FDA realizes its mistakes, especially in bowing to political pressure from unscrupulous convicted felons, their friends, and others, and overclocks in the other direction. This then results in events like the one from last week, when MDMA was denied for PTSD treatment. Now it will take us forever to find out if the rejection was justified. 

Thus what we need are smarter, scientific reviews that don't arise from undue political pressure and self-destructive book reviews. At the end of the day, I am sure, Califf is not scanning unscrupulous publications for book reviews to worry about the pace at which his agency should approve drugs or devices. At least, I hope he has better things to read. 

Using machine learning techniques, better clinical data, honest reviews, dedicated panels of humans and other commonsense approaches, glacial or not, the FDA can strive to keep patients alive in the decades to come!  There will be plenty of time to discuss these techniques, and for now, I urge you to stick to the "glacial" timelines in an era where the glaciers are melting. 

References:

1. The self-destructive book review on wsj: https://www.wsj.com/arts-culture/books/frances-

oldham-kelsey-the-fda-and-the-battle-against-thalidomide-review-the-noble-bureaucrat-7f1fc379

2. The book:https://www.amazon.com/Frances-Oldham-Kelsey-against-Thalidomide/dp/0197632548

3. The FDA's aduhelm misadventure: https://www.nbcnews.com/health/health-news/fda-broke-protocols-approving-biogen-alzheimers-drug-congressional-rep-rcna63662

4. The FDA colludes with your favorite surgical device manufacturers: https://chaaraka.blogspot.com/2019/04/so-what-will-fdas-secret-hidden.html

5. The FDA's sudden repugnance for MDMA: https://www.nbcnews.com/health/health-news/fda-panel-rejects-first-mdma-treatment-deep-concerns-flawed-trials-rcna155325

6. The cover image for the blog post: https://www.pexels.com/photo/selective-focus-photo-of-pile-of-assorted-title-books-1148399/

How Healthy are we? Pondering the status quo on World Health Day

The good folks at JDRF woke me up on a lazy Sunday morning with an email about April 7th being World Health Day. As I lay in bed listening to some Carnatic Music renditions (a form of South Indian music), a sometimes-morning routine for me on weekends, I noodled on the topic of health. For a while now, since we heard about the second ever patient to be rid of HIV, I have been thinking about writing a post about how slow progress in medicine has been, and how much progress is yet to be made.

Yes, the post is somber in many ways, but the goal here is not to depress or take away from the progress we have made, but to serve as a yardstick for where we need to go from here.

1. AIDS/HIV

The HIV virus is the most impacting of several that jumped to humans from other animals - a phenomenon termed Zoonosis. Humans have been suffering from HIV infections and its consequence, AIDS, for just about 5 decades now, and we have so far cured TWO patients, and that is, only because of their special circumstances!

Given the fatal consequences, and the innumerable deaths the virus has led to, it stands in stark contrast to other victories of the past, such as against smallpox, another consequence of Zoonosis.

Yes, the HIV virus is very tricky and is ancient (it appears the Chimpanzees fought it off millennia ago). However, it shows that for all our understanding of chemistry, biology, microbiology, virology and genetics, we are as of now, quite unequal to the task.

And as I mentioned above, both patients who are in remission for HIV had special circumstances, and their doctors were courageous, taking more risks than most have. And that is one of several problems I wish to discuss in this post.

2. Cancer

Yes, decades of promises and billions of dollars we have no cure for cancer, except for the most incidental cases. In fact, we don't even understand cancer well enough. Theories have come and gone, resembling fads of yesteryears.

For the most part, cancer therapies resemble what I call "fancy bloodletting"with the rare exception, such as with thyroid cancer. Thyroid cancer, in some cases can be cured by injecting radioactive Iodine, which the thyroid gland laps greedily, as it evolved to (it will take up Iodine, radioactive or otherwise, that is). You then wait as the radioactive Iodine destroys the cancerous thyroid cells.

You may then ask, why we haven't found extended this type of solution to mos types of cancer. Well, we haven't done a good job of understanding genetics, biomarkers and the other aspects of biological science which would provide us with the tools necessary to advance cancer therapy past horrifying drugs or radiation.

I personally find it appalling that it is not illegal to use "inoperable tumor" as an excuse to send a patient home to die!

3. Chronic "Lifestyle" Diseases

Now, we all share the blame for this. As societies prosper, especially in developing countries like India, unhealthy lifestyles are leading to High Blood Pressure, Obesity, Diabetes and other conditions that cause decline in Quality of Life and in some cases, also lead to mortality. In the past couple of decades, there has been some modicum of progress with respect to blood pressure (no, NOT renal denervation, more on that in a minute), diabetes and cardiovascular care, but people are making themselves sicker faster than medicine can catch up. More awareness will get us part of the way, but this is one of those areas of health that can be tackled as a team effort.

4. Barbarism, Renal Denervation and the Poverty of R&D

When I first learned of renal denervation, I was immediately alarmed. It continues to irk me today, that this was not the universal reaction. Maybe I am overly sensitive to such nonsense, which is whata this is, because I have come across this before. I was once an intern at a company that burned millions of dollars (!) on the path to treating migraine with visual aura by closing the inter-atrial septum. Yeah!

Renal Denervation is based on some "research" around the middle of the previous century, in a Mary-Shelley-esque manner, someone toasted renal nerves to notice a drop in blood pressure. Without much further research into the long term effects of doing this, someone dusted this off the basement of some library and turned it into Ardian, which Medtronic then hyped the medical device industry into a frenzy, by ridiculously overpricing Ardian during the acquisition.

I do not buy the theory that Medtronic "botched' the clinical trials. I think humanity is lucky in that pharmaceuticals have progressed enough to be better than the weed-killer approach to blood pressure management.

What we should truly focus on is this - the medical device industry is really behind the curve on basic research. Too much of the focus is on development, some of it quite mindless, like the use of drills to remove arterial plaque!

This poverty of R&D efforts is one of the key reasons why progress in medicine has been so slow. 

5. Private Fraud and other Misbehavior

Elizabeth Holmes and Theranos are but the latest examples of people and organizations behaving badly. History is full of such examples, and this is in fact how the FDA came into existence. That, there is an assault underfoot to water down the FDA will be discussed momentarily.

The way some companies approach regulations is not as the framework to work within, but the dilapidated fencing to test aggressively for weaknesses. The lack of ethics causes problems for medicine and society.

6. Bad Governance

Just a couple of days ago, I posted about the secret database FDA maintained and helped an unknown number of medical devices cover up a further unknown adverse medical device events, masking the true limits of such devices and the harm caused by them. Spanning multiple administrations, this struck a blow to the very heart of why the FDA was created in the first place.

World over, many governments are undermining healthcare, in more ways than one, eventually harming both current and future generations.

7. Medicine Inequality

Under-served populations suffer from many inequalities in medicine. The aged, women, people below the poverty line, entire regions of the planet - several cohorts constitute under-served populations. Pricing is one. Access is another. The deliberate act of making medical devices disposable, fundamental to the chosen business model for many organizations in the industry is another. Patents, regulatory pathways, corporate greed - the factors abound. Suffice it to say, much work remains to be done.


Conclusion - Opportunities abound! 

The aforementioned points can be seen one of two ways. One way would be to be angry and depressed. The more positive approach would be to see all of these as opportunities ripe for innovation to cause true, lasting change.

That is the purpose and spirit with which this post was written.

Rooting out unethical behavior, bad governance, downright criminal behavior, making medicine affordable and equal, causing real technological progress, improving Quality of Life (QoL), reducing morbidity and mortality are all challenges we can take up and whittle down!

So, Happy World Health Day!

As usual, if you want to be reminded of the event annually, here is an event:




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References:

1. Map of the World: https://www.pexels.com/photo/black-green-brown-continent-87652/

2. Blood Draw Image: https://unsplash.com/photos/Zp7ebyti3MU

3. Image of Breast Cancer Ribbon: https://www.pexels.com/photo/awareness-cancer-design-pink-579474/

4. Image of Blood Testing Equipment: https://www.pexels.com/photo/health-medical-medicine-diet-46173/

5. Image of Broken Glass: https://burst.shopify.com/photos/broken-shards-of-glass-hanging-in-a-boarded-up-window?q=looking+glass

6. Image of Syringe: https://isorepublic.com/photo/syringe-with-blood/

7. Image of Hammer: https://www.pexels.com/photo/close-up-court-courthouse-hammer-534204/

8. Image of Beautiful Old Lady: https://www.pexels.com/photo/grandmother-making-faces-34540/

9. Image of Cheerful Team: https://www.pexels.com/photo/group-of-people-raising-right-hand-1059120/

So, what will the FDA's secret hidden database lay bare?

NOTE: By now, if you haven't heard of the secret database the FDA has been keeping to help companies hide adverse events, I'd say you are not keeping up! I will supply a couple of links for you to peruse to get yourself up to speed.

ON THE ETHICS: It is key to discuss the ethics or rather their absence, in detail. However, I want to focus on something else for now. I am curious about what we will learn, and I want to focus on that. However, I will leave you with a couple of points to ponder:

1. It is typical for controversies to take a political bent. But here is an alarming example of something that started with one administration, and sustained through several.

2. There are something like 780+ federal agencies, that we know of. Just the potential of the spread of this type of bold unethical behavior, that will go unpunished is just jarring!

3. Congress is completely asleep at the wheel!

4. THIS ONE IS KEY: How many company executives know about this, have participated in this, and what are the implications of all this?

What I Expect We Will Learn

1. Just how many medical devices and their manufacturers been accessing the database?

2. What type of adverse events were being hidden?

3. The relationship between adverse events that we were made aware of, previously and what was in the database. Do we get a chance to just sum them up and say, "well, we thought this device had 5 adverse events per year, and now we know it was 25 per year because we found thata on an average, 20 were being hidden per year?"

4. What if certain types of adverse events were hidden from us?  What if injuries were made public, but deaths hidden?

5. What if companies got preferential treatment in terms of access to the database and how was this decided?

6. To what extent can we answer the question: how far was the true harm to patients?

Lost Opportunities

1. Imagine how many start ups could have germinated to solve issues caused by devices that people falsely believed to be better than they are!

2. Imagine how many patients could have chosen alternate treatments or devices. One also has to wonder how many credible lawsuits were not filed owing to the fact that the evidence was hidden!!

3. Doctors could have better cared for their patients, and provided them with adequate warnings, alternates or protection.

4. The FDA is meant to protect us. Medical Device Companies are supposed to be ethical. And now, it is anyone's guess how deep the loss of credibility is going to go!!!



There is more to come

This database raises far more questions and alarms. I am sure in the days, weeks and months to come, we will discuss more of these issues, as details become apparent. Currently, we know something like 3X the data was hidden, in just a year, per Star Tribune. Who knows what the real depth of the problem is.

Subscribe and Support, Please! 

Did you enjoy this post? Please subscribe for more updates, using the sidebar. Have ideas or blog posts you'd like to see here? Contact me at yamanoor at gmail dot com.

References:

1.Star Tribune: http://www.startribune.com/fda-says-it-will-make-more-info-available-on-medical-device-problems/507788372/

2.The Kaiser Health News Report: https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/

3. Image of Woman: https://www.pexels.com/photo/black-and-white-black-and-white-depressed-depression-568025/

4. Image of Right and Wrong: https://pixabay.com/photos/ethics-right-wrong-ethical-moral-2991600/

5. Image of Seated Person: https://stocksnap.io/photo/95TESM9499

Quick Post: The FDA takes part of a much needed change of approach towards homeopathic "remedies"

Traditional/Alternate non-allopathy medicine certainly has a place in the healthcare industry. However, the problem is that a lot of these are entirely devoid of any basis in scientific evidence. These medications can provide, limited healing for a small subset of simple disease conditions at best. For the more aggressive disease conditions such as cancer, where the mechanism of disease itself is not understood well under most circumstances, they quickly fall apart.

That is not the only issue with the practices. There are no cGMP practices, and usually no standard controls on how the drugs are manufactured. Routine examinations have found that Ayurvedic and Homeopathic drugs are found to have dangerous contaminants (worse in Ayurveda than in Homeopathy - links provided below).

Remember, this is not a criticism of the forms of alternate medicine.

It is that a lot of these drugs are being manufactured without the controls afforded to the mainstream (if you can call it that) pharmaceuticals. This is a non-trivial problem. From poisoning to a range of other side-effects, this can actually affect the health of unsuspecting patients.

The Key Issue

The Key Issue is however that the purveyors of these drugs over-promise, with no scientific backing. One key danger, as you can imagine, is that in lieu of actually taking drugs that actually work, patients could opt for drugs that do little, or nothing and in many cases, cause actual harm. This is really a huge problem.

The FDA steps in

In 1988, the FDA decided it would not regulate homeopathic drugs. This decision reverses that. However, this doesn't go far enough. Here are some quick thoughts:

1. The new policy unveiled by the FDA only covers certain categories of homeopathic drugs - for infants and children and more serious diseases such as heart conditions and cancer, as well as for drugs that contain certain substances, such as Belladonna.

2. It doesn't cover manufacturing and contamination issues on a global scale.

3. It also doesn't talk about requiring more scientific rigor, per se. I get that more scrutiny would indicate a demand for scientific rigor, but that needs to be explicitly stated. Why? Because if you follow mainstream medicine, and create a drug or a device, you are EXPECTED to conduct trials, have the work examined by experts in medicine, get the work published and so on. You are ALSO expected to do post-market follow up. It is awfully dangerous that even the shifted policies don't give me the comfort that any of this will be imposed on homeopathic medicine.

4. In other good news, the FTC is joining the FDA in some of the enforcement and so things are looking up from a safety and efficacy as well as labeling point of view.

Conclusion

However, the FDA's shift in policy is a welcome change in the right direction. Again, it is not a criticism of alternate forms of medicine, I just think that in the interest of patients, there has to be scientific rigor, honest marketing, follow up and cGMP implemented. Let us see what Scott Gottlieb's FDA does as time goes on!

References:

1. The FDA on regulating homeopathic medicine: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589243.htm

2. Image, Courtesy Pexels: https://www.pexels.com/photo/tablet-medical-medicine-grind-39522/

3. Contamination in Ayurvedic Medicine: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2755247/

4. Concern for contaminants in Homeopathic Medicine: https://www.ncbi.nlm.nih.gov/pubmed/20674842

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It is high time the FDA considers taking down DTC ads rather than confounding them further

Word is out that the FDA is trying to curtail the number of side-effects stated in Direct-To-Consumer (DTC) pharmaceutical advertisements, in an apparent effort to try and get consumers to understand the key side effects and remember them. This is apparently considered a benefit to the consumer. How? Don't ask me. I think this is a bad idea, and the focus should be to de-emphasize DTC, so that prescribing medicine goes back in the practitioners' courts and pharmaceutical companies can focus on R&D and Translational Research spending. For years now, I have advocated AGAINST DTC ads.

1. Why am I against DTC ads?

The United States is one of the few countries that actually allows DTC ads of this nature. And I have a few critical reasons why many of us, and not just me, are against DTC ads.

1.1 An uninformed public is either given unnecessary hope, with some advertisements. Advertisements have a misleading way of sounding positive, and appear to offer a single point solution, that is quite effective. Needless to say, we don't know how age, sex, gender and other factors differentiate the effectiveness of treatments for many conditions in various patient groups. And where, we do know the effects, the advertisements simply ignore to state such information. Sure, there too, we could be like the FDA and pretend that information overload is the problem. However, when the Doctor finally informs the patient that the drug wont work on them (or tell them so after a few courses of treatment and the associated side effects take their toll), there are the 5 stages of grief, the second opinions, the ensuing loss of trust, the negative effects are too numerous to recount.

1.2 Confusion is the next problem. As the old joke in many television situation comedies (which run the advertisements they mock) that a simple headache medicine could include side-effects ranging from death to, yes, you guessed it, headaches.

Now, let us say that you found a headache medicine or allergy medicine that did indeed have side effects ranging from death to headaches. If you mentioned death only, does that make the patient feel relieved or better prepared? Or, if you leave out the headaches, and the Doctor only mentions them in passing, does the patient take that side-effect seriously? Do they decide to take the medicine? And if they are indeed plagued by headaches from taking the medication, then what?

1.3 Unnecessary Fear is the next problem. Imagine watching a cholesterol ad that warns you of cancer, heart disease or rectal bleeding? This is why the solution is not to MAGNIFY the main side effects. That somehow just makes the problem worse, not better.

1.4 The drug ads are also comically nightmarish. First of all, who in real life walks around telling people they have "moderate to severe Crohn's disease". If they did, it would actually be indicative that they need help of a different kind. And some of the so-called patients appear so deliriously happy after medicating themselves, it almost appears that something else is being advertised. Are you surprised at all that the United States is suffering from an opioid crisis?

Then there are the ads that are downright creepy. While the FDA has agonized over the presence of dogs, I would be more worried about ads that show a patient wandering through some ghoulish cartoon world, right out of the mind of someone who has consumed quite a quantity of hallucinogenic mushrooms.

Now, let me dismantle the reasoning behind this misguided effort at distilling DTC ads to accentuate fear, confusion and misinformation:

2.1. It is based on a study conducted with almost no rigor. The FDA asked 1500 people to watch a few advertisements, asked a few questions and mixed up a cocktail of street-side psychology and came to conclusions. This makes absolutely no sense at all. And this somehow took them years to get to.

2.2. Who decided information retention is the problem? This is what perplexes me. The problem here is patients who probably don't even understand what they ail from fully well, walking into the Doctor's office, demanding to be prescribed WEIRDCONSONANTFILLEDNAMEERASTUMINALIBAB because they watched an ad, that, sure, told them they could have nasal bleeding or brain cancer and something something, but that woman was up the next day smelling flowers and high-five-ing strangers. You see, if we get past all that distraction - the basic problem is - patients should not be making any decisions on their prescription (why have Doctors go through medical school at all then?) and should really leave this to professionals.

2.3. When was the last time a practitioner said, "Phew, I almost forgot about, but I am glad Patient X brought up EASYTOFORGETEXA for his moderate to severe such and such"? (Yes, the "moderate to severe" thing PISSES ME OFF, and to be clear, there is nothing moderate about how much it pisses me off.)

The Solution

This is one of several favorite quotes from one of the shows I love the most, House M.D. :

Dr. Gregory House: You wake up in the morning, your paint's peeling, your curtains are gone, and the water is boiling. Which problem do you deal with first?
Dr. Eric Foreman: House!
Dr. Gregory House: None of them! The building's on fire!

See, the problem is not that there is too much information in DTC ads, or that the amount of side effects retained is the problem. The dog running around in the ad is most certainly NOT the problem.

The problem is the burning house, that is, the fact that we unleash ads about NEARXIGA on people till 11PM, after which the "Non-Attorney Spokesperson" shows up and scares the living lights out of you and does not leave before letting you know that the FDA knows NEARXIGA kills, and equipped with this information, should you notice you've just died, call them.

What the FDA needs to do is to advice pharmaceutical companies to advertise as less of their drugs as possible and focus on spending money over new and more effective therapies. It is that simple. And in fact, that is exactly what a "business friendly" FDA ought to do.

And everyone should watch Dr. House.

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Did you enjoy this post? Please subscribe for more updates, using the sidebar. Have ideas or blog posts you'd like to see here? Contact me at yamanoor at gmail dot com.

References:

1. The Forbes Article: https://www.forbes.com/sites/arleneweintraub/2017/08/29/fdas-gottlieb-wants-to-rein-in-risk-info-in-drug-ads-but-will-he-succeed/#74f9bf7e2042

2. Dr. House Quotes: http://www.imdb.com/title/tt0774238/quotes

3. Image Courtesy, Pexels: https://www.pexels.com/photo/colors-colours-health-medicine-143654/

Scott Gottlieb's Magical Risk-Based Powers and Orphan Drug Applications

Interesting Numbers

In a Senate Hearing today, FDA Director said that there are over 200 orphan designation applications pending with the agency. He then promised a turnaround on ALL (yup, you read that right) pending applications within 90 days. For anyone interested, that is approximately 2.2 applications per day. Now assume a day is 8 hours and FDA employees are jailed to their desks even on weekends...

A few days ago, I was positive after reading his blog post and I even reported on it here. Now, I am just perplexed to say the least (and pretend that I do not want to say something else altogether!). The FDA is not a clearing agency. Orphan designation requests are not like Fishing Permits or Back Country Hiking Permits. How could we expect any relevant level of review under such stringent timelines?

I understand it is important to clear back logs. I understand the importance of orphan drugs/devices/diagnostics and how anxious patients must be. But there is efficiency and then, there is general madness.

Trust Issues

The FDA's success in keeping US patients safe is seminal to ongoing trust people place on it. Slowly, reluctantly, agencies world over are following the FDA. To go on a mad rampage, potentially endangering patient safety to just move rapidly on applications makes for bad precedent. And, without providing any actual strategy, Gottlieb simply repeats the words "risk based approach".

The magical incantation?

You hear risk based tools once, and you go, okay, that sounds nice. When someone keeps offering the same thing as a "fix it" for everything, you start getting suspicious. Earlier this week, he touted risk-based tools as means to approve digital health applications. Okay. And I do see how they can be applied on all applications. But there is more to a review of applications.

In his defense, he did also say "modern" tools as well, and wants to improve the orphan designation application form. However, none of this sounds too comforting when taken in context.. Yes, risk based approaches to regulation will help improve things. However, they are not a panacea. You obviously need good quality reasoning. Is the condition indeed rare? Are there indeed no other drugs/devices that work? Is the applicant trying to abuse the orphan designation to take advantage of anxious patients? These are all important considerations, and I fail to see, how in about 3.5 hours or so, a decision on all these pertinent questions can be made. This is essentially what Gottlieb promised Congress.

A warning on orphan designations

Some in industry might see dollar signs and be thrilled with this laissez-faire attitude. However, I will remind you, that all is well, only till something goes wrong. Already, the pricing of orphan drugs has created quite a storm, with many questioning whether the Orphan Drug Law is being abused. If applications get a very light review, and the result is either more expensive, poorly effective drugs and devices, or if it results in serious patient injury, it will be a disaster. Patients and advocates engaged in less covered disease and therapy areas are already very vocal and will not excuse failure. Therefore, I sincerely hope this is not a thinly veiled attempt to reduce the quality of the FDA review process.

Since I have always been interested in oprhan drugs, I will keep a close eye to see how he directs the agency to rapidly respond to applications, with the level of scientific review, focused on safety and effectiveness and report back.

References:

1. The RAPS Article: http://www.raps.org/Regulatory-Focus/News/2017/06/20/27941/FDA-Commissioner-Vows-to-Eliminate-Backlog-of-Orphan-Drug-Designation-Requests/?utm_source=Email&utm_medium=Informz&utm_campaign=Informz-Emails

2. Image Courtesy, Pexels: https://www.pexels.com/photo/blur-bokeh-dark-evening-75360/

The FDA promises a path forward, in digital health and other areas...

I find it quite interesting that, just yesterday, I had complained about how the FDA and other regulatory agencies are behind the curve on cyber-security, and today, at least with regard to digital health, the new FDA Commissioner Scott Gottlieb is promising some key changes and efforts going forward. This is, to say the least, heartening to hear, especially since at least some of the efforts continue on from the previous administration and that is a good thing. Not only do we get continuity, but also rapid progress as opposed to a back to the slate approach. I only hope that in the long run, the FDA stays guarded against haphazard deregulation, the kind that eventually caused patient injury and sparked anger and intense debate in 2007. I also want to remind everyone that the FDA has only provided forward looking promises, and only when these things come to fruition would a better picture emerge.

Most of the information, comes directly from a blog post by Scott Gottlieb (that quite irritatingly leaves out the definite article when addressing the FDA throughout the post). The post is linked below, along with an article from CNBC with some caricatured, over the top reactions. I wanted to discuss a few, salient points here.

The Stratified Regulation of Digital Health

When it comes to digital health, things have been haphazard so far. Some organizations decided by themselves that regulation did not apply to them. Ever guarded about their role, the FDA stepped in and refused to simply give up. Then came the uproar about what should and shouldn't be regulated. As Gottlieb points out, the 21st Century Cures Act rids the FDA of the need to act on simple applications, such as healthcare lifestyle/motivational mobile apps and administrative software programs. This is a great step forward. However, for example, blood glucose monitors and accessories, pictured above will continue to be regulated (in the past, poor design decision making led to patient death and a company shut down).

Clinical Decision Support (CDS) Software

Clinical Decision Support Software programs, either by themselves, or in conjunction with medical devices will provide recommendations for diagnoses, treatment, dosages etc. As such the FDA has regulated them without guidance and this has led to much stress and discussion. There has been a long, ongoing effort to try and make some clarity available, and it appears that the FDA is finally promising (mind you, that is all we have as of now) that this will happen. What exact shape and form this will take is unclear as of now.

Something, Something, Opioid Crisis

The opioid crisis is real, and action is necessary, but from Gottlieb's writing, it is unclear what the FDA will do. Past contests and prizes are great, but if they plan to do something more concrete, I was not able to glean any of that from the blog post.

Pilot Programs and Cutesy Abbreviations

So today, through Gottlieb's blog post, I was introduced to a new term - Software As a Medical Device (SaMD). Apparently, a third party certification agency will allow low risk devices to be "per-certified" and marketed without FDA pre-market review, and high risk devices will be undergo an FDA review. Who will do this classification is unclear from the blog post, and frankly worries me. Information on an apparent pilot underway to accomplish this is also thin on details.

On Third Parties and the Risk Based Approach

Terms such as "third party certification agencies" make me a bit squeamish. Almost never in the open, but heavily so in private, Regulatory Professionals in the Industry writhe, squirm and complain about how the third party certification agencies that oversee CE Marking wreak havoc on their day to day jobs. Privatization is always a mainstay of the GOP agenda, but it is very disconcerting to see this discussed in the context of regulation. One fundamental qualifier for the FDA has been that, holding devices, software, pharmaceuticals and much more to a very high standard has proven quite (safe and) effective for those of us here in the US. I wonder, if the pilot, is but a pilot to extend this "third party" business into other areas that come under FDA purview.

Sure, it is good for businesses and a new crop of companies and consultants it will foment, but is it good for the US consumer in the long run? My answer is - NO!

I don't understand why the FDA would have difficulties doing the classification and the consequential pre-certification. This is something that gives me a long pause, but let's wait and see how the pilot pans out and what comes of the actual efforts at guidance and regulation after.

Over all, medical device and pharmaceutical companies already consider a risk based approach in design and manufacture and the FDA also encourages this. This part, I like. It is important to focus on critical, high risk items that have bigger impacts and not on the minor details.

National Evaluation System for health Technology (NEST)

This was fun to learn about. Through the Medical Device Innovation Consortium (MDIC), post market data is apparently to be made available to engineers and designers to improve product design, by 2019. This is quite interesting and exactly the kind of innovation that SHOULD be outsourced to "third parties" and made available to all. You wont hear me disputing this one.


Conclusion

Scott Gottlieb's blog post appears to be well thought out. It makes promises, most, if not all of which appear lofty and beneficial. However, as I have mentioned previously, these are just onward looking statements and only time will tell how they all play out. So, I would advice everyone to take a more measured approach and wait for more concrete information to emerge.

References:

1. Scott Gottlieb's Blog Post: https://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-for-digital-health-devices/

2. An unjustifiably jubilant CNBC Article: http://www.cnbc.com/2017/06/15/fda-commissioner-scott-gottlieb-outlines-new-digital-health-strategy.html

3. A cool Fiercehealthcare article on CDS Software Regulation Guidance: http://www.fiercehealthcare.com/special-report/fda-s-approach-to-clinical-decision-support-software-a-brief-summary

4. Image, Courtesy Pexels: https://www.pexels.com/photo/health-medical-medicine-diet-46173/

No improvements in cyber-security for Pacemakers and Implantable Cardioverter Defibrillators (ICDs)

Cyber-security of medical devices is a critical issue, and surprisingly, one that still fails to gain appropriate attention, despite repeated publications and shocking revelations. The FDA has made some efforts, but as you will see from the report linked below, the efforts clearly fall short of what is actually needed. Through LinkedIn, I found an article and a report on ICD/Pacemaker security issues, that was revealing.

I will let you read the report, an easy read, and use this post to address some high level concerns based on what I learned. Here are a few concerns/thoughts:

1. It is clear that the FDA and other regulators don't fully understand cyber-security issues associated with medical devices. In fact, I would venture, most of us don't, at least not enough to pass robust regulations. Yes, it is a learning process and should happen in iterations, but the rate of progress and the quality of the outcomes are quite poor, when it comes to implementing cyber-security in devices. Even the basics appear to have fallen through the cracks - such as data encryption, hardware and code/firmware obfuscation, etc., which I had simply assumed were foregone conclusions, having seen a cyber-security upgrade to a product through to market that went well above the basics.

2. It is a bit surprising to learn that off-the-shelf hardware, and third party libraries are freely used. I thought, Class III devices would, by necessity see customization at every level. While this has been educational, it represents another layer of failure in security implementation. I have seen simple $20 - $30 prototype level sensors and such come with epoxy dipped circuits that were essentially impossible to reverse engineer. I can see how due to functionality concerns and medical device regulations, this is not the solution you'd see medical device manufacturers use, but clearly, some form of encryption and lock-out should be mandated.

3. Re-sale and re-use of devices is always an area of debate. Manufacturers would like to stop them altogether, first for financial reasons; reprocessors and resellers would love to be given unbridled access. Common ground is important, and it should be fundamentally unacceptable for un-encrypted (!), patient-data laden devices to show up online for sale (per the report, this has happened). Either data should be encrypted - how this is not mandated, still surprises me, or, at a minimum, anyone reselling any medical devices online should be required to "flash" devices/sub-systems that carry patient data.

4. From a business standpoint, having seen some companies, that were not necessarily visionary, but had learned through dealing with counterfeit capital goods and disposables, enforce encryption and obfuscation, I fail to see how all 4 manufacturers that make expensive and critical devices such as ICDs simply stand by and ignore fundamental security implementations. It further perplexes me that the FDA does not require stringent security features!

5. When it comes to physician programmers, I can see how, within the clinical setting, it would be dangerous to waste time entering user names and passwords when potentially dealing with critically ill patients, there should be a global lock on such devices the minute they are outside a clinical setting. The ability of random third parties (as the researchers at WhiteScope did, for example) to obtain these programmers and access the removable (!) hardware through unlocked (!) USB ports etc., is simply unacceptable. This shows that both the manufacturers and the regulatory agencies lack vision in implementing good, logical security systems. This is a very dangerous notion and immediate correction is essential. But, like the mice at the meeting, one has to sit and wonder, who will bell the cat?!

6. This is a bit of a repetition, but I see this as the core of the issue. Medical Device Manufacturers are not taking leadership on product and patient security. The FDA, veritably, the world's leading medical device regulatory agency is not. Therefore, no one is! We don't need obscure, soporific "guidance documents". I am sure the FDA has published a handful of these and will probably put out a handful more. What appears to be missing is a clear, forward looking visionary form of leadership, that doesn't just get bogged down on encrypting software code and locking down hard drives, but plans ahead to evolving paradigms and problems in cyber-security, such as the spread of ransomware for example. Given that off-the-shelf components, common architecture, readable code and data are used, as well as the fact that all components in the system/network can be purchased easily, all it will take is for an unscrupulous group of individuals to buy these devices, decode the overtly simple security features and then sell the mechanisms to nefarious groups, or decide to hold groups of patients, individuals or entire hospital systems hostage.

Conclusion

The problem of lax/absent cyber-security in medical devices of all kinds, is present and continues to evolve alongside the emergence of digital health and digitization in general. I can sit here and spin doom and gloom all day and all night, but what I am left to wonder about, instead is, given all we know, when and from where will we see this vision and leadership emerge from. Right now, I can only ask the question and have no answers to offer. If you can think of any, do let me know.

References:

1. The Healthcare IT News Article: http://www.healthcareitnews.com/news/pacemaker-device-security-audit-finds-8600-flaws-some-potentially-deadly

2. The WhiteScope Report: https://drive.google.com/file/d/0B_GspGER4QQTYkJfaVlBeGVCSW8/view

3. Image, Courtesy Pexels: https://www.pexels.com/photo/blur-bright-business-codes-207580/

On Scott Brown's unfactual rant...

It is like a scene from a bad cowboy movie. Or, a Chuck Norris episode, with GMC trucks and everything. Scott Brown was probably "coached" by his friends at some of the Biotech companies which have impressed on how they have to "train" FDA officials who are regulating them.

Equipped with this, he went and stood in front of a whole bunch of his Biotech friends in some dog and pony show in Massachusetts in his probably inimitable style, that gives no credence to facts or reality.

Here is a dose of what he is purported to have set. "Whether it’s the FDA, EPA or the “ABCDEFG, you name it — there’s so much overregulation right now,” he said. “When you go overseas, the processes are down, they’re set.”".

Too bad, entry into the U.S. Senate is not even under-regulated you say?

Well, according to Scott Brown's constituents, you have to drive certain vehicles, and take money from donors and recite what they ask you to say. See, the process are down, they're set!

Fighting with facts!

You may not like how the FDA regulates things. And if you choose to do so, you can fight in a way that doesn't make you look like a special-plastic smelling aficionado! Just don't do what Scotty here has done - ranting so poorly that one of the FDA spokespeople who he might deem "lacking in mental capability" was able to come out and say that Scott Brown is mostly, if not completely wrong - without having to try hard! As to mental capabilities, what do they say about it taking one to knowing...

Given that more devices and drugs have been approved over the past decade than ever before, and given that the US is still one of the safest bets as far as medical standards go, Scott Brown's statements make him look very eligible to hire himself out to children's parties for some quality entertainment, which some cynical people might deem all politicians to be eligible for...

Cacophony

Armed with the unfortunate ability that renders any ill-minded person to register "non-profits" in the US, a couple of them have engaged in all kinds of cacophony about "over regulation", "loss of competitiveness" and other terms that they can express without developing even a superfluous understanding for.

While the people of a state should observe and regulate their regulatory agencies, it has to be done without rants and forged reports. Bring up the facts, and urge patient-oriented action, not profit or donor oriented action.

Consulting "Experts" - the wrong way

On the other hand, Senator Franken got too excited and has asked the FDA to consult "experts" in the device industry before making changes to device approval processes. Er., should the cop stop you on the freeway and consult you on whether you were speeding or how much the ticket should cost you?

The right way

Health advocacy agencies that don't take money from biotech and device firms; consumer non-profits and other members of the public who have an understanding that goes beyond the sound-bites handed to US senators should be the ones most actively engaged in discussing any industry's state of regulations.

Senators, biotech companies and others have a right to fight regulations too, if they plan to do it with facts, sanity and coherence. That day, pigs plan to fly...

References:

1. http://www.bostonherald.com/business/technology/general/view/2011_0622fda_fends_off_browns_attacks/srvc=home&position=also

2. http://www.fiercebiotech.com/story/sen-brown-accuses-arbitrary-fda-crushing-biotechs/2011-06-22?utm_medium=nl&utm_source=internal

3. http://www.medcitynews.com/2011/06/sen-franken-to-shuren-get-industry-input-before-changing-510k-system/

Starting a medical device company? You are better off without some of these "VC"s!

When I first learned about "entrepreneurship" and "venture capital" it didn't make much sense to me. Over time, I thought these "VCs" would be respectable old ladies and gentlemen with graying hair and gold-rimmed spectacles full of worldly knowledge just waiting to share that with young people.

What can I say? I was 23.

A few years of "schlepping" business plans of varying sizes and forms later, I don't think so. Oh wait! Am I losing any future opportunities to beg around for money with quaint little PowerPoint presentations?

Well, let's put it this way. No one who cannot take some criticism is considered grown up and I really don't want to share my future business ideas with over-grown Peter Pans. I am sure there are good VCs and there are bad VCs. Good VCs look for returns from functional business plans...

Surveys gone wild

What got me riled up anyway?

Apparently VCs local to New England responded anonymously to a survey conducted by MassDevice. Their fundamental rant? Healthcare reform is not the problem, the FDA and it's reform is! And I am not singling out this survey, I have seen such "responses" before as well.

Apparently, the FDA is considered so risky that some of these "anonymous" VCs don't even invest in companies that have FDA "exposure".

What the hell kind of a medical device company does not have FDA exposure?

Maybe, the ones that make tongue depressors and bike helmets. I gotta tell you, there's not much margin in tongue depressors - China's got it covered anyway, and I still worry that we don't check Class I devices enough to make sure they don't end up with a fun cornucopia of Lead, Cadmium and Melamine.

If we scare people enough, they will make the FDA back off...

First things first. If any of these glorified pawn brokers look at your business plan and say they are "concerned" because of your "FDA Exposure", step away slowly and gently.

A venture capitalist who does not understand the approval process is not worth anything for you regardless of how many buckets of money they promise will show up on the term-sheet. It is not just the entrepreneur that needs to understand the importance of an FDA approval to your very existence.

FDA approval is not a "risk management" issue or a "price pressure" issue or any of the pretty little CYA-terms they teach you at the MBA-for-real-dummies school.

The entrepreneur who founds the company, brings in angel and VC money should know this. The CEO planted by the VC firm needs to know this. The Board of Director needs to know this. The people you hire need to know this.

The Right Perspective - Interview your VCs before you take their money

I don't want to poach MassDevice, so I want you to read about these VCs yourself. Unlucky for you, you don't know who they are so that you can avoid them like er, we will just move on.

You plan to interview your VP of R&D right? You plan to interview the M.E. interns and the engineers and the clinical folks and the assemblers and such, right?

You will talk to Joe and Sarah before you hire Vinny to help you with V&V correct?

Well, do the same thing for the VCs.

Interviewing the VCs - The questions to consider

Tough times can lead to good change. Be part of the change. Until you stare the horse in the mouth, you won't know if she is a gift-horse. To help weed out the unfavorable horses, here are some things to consider:

1. Try to have a frank conversation with your future investors. Be respectful, but assertive. Watch for signs of gentle prodding to "cut corners" on the regulatory side or the ethical side.

2. Snoop around - talk to other organizations that have taken money from these investors. Find out how the board meetings go. Find out what kind of pressure they have been under.

3. Well before you get the term sheet, your VCs will do a background check on you. Don't hesitate to do the same. You really need to know where your money is coming from.

What the hell am I saying? Isn't this 2010 where money is scarce and because of price-pressure and R&D profit ratio blah blah...

Yeah, right. Look, for all the things these guys say about how pharma and biotech are winners and how running around naked "exposing" yourself to the FDA is making you look bad (don't actually expose yourself to the FDA, it won't help), trust me, who are they kidding?

Understand the real game

First off, if you have been paying close enough attention, investing in pharmaceutical and biotechnology plans have moved into a rather complex arrangement. Nowadays no one does the classic angel plus A through F rounds that you learn in MBA schools.

Sometimes, companies get lucky and rather do single large rounds of $100 - $150 million. That is more than what a good, ethical medical device company would ever need to raise on it's way to profitability.

Other times, smaller pharmas enter into "milestone agreements" simply because the clinical trials needed for their success make them so hot, that even the VCs cannot handle them. So, really, ask again, who are they kidding?

I read all these surveys and by gosh, will medical device investment ever return again?

Ever since the healthcare reform looked like it would pass, a whole bunch of folks have taken to this notion that we are all idiots. They keep throwing tea bags and dumb rationale at us to foist their empty threats.

In truth, the economy will recover - the recession ended some time late last summer or thereabouts. Good ideas will get funded. Then the bad ideas will get funded. Everyone will want their hand in the cookie jar(yes, I am all about those cliches). And that is why these VCs want to be "anonymous".

If you have been in the funding scene recently at all, you might have noticed a few changes. Primarily, you might have noticed some very competitive and knowledgeable VC firms from China. Yeah, they hurt us from below and from the top. And remember, it's not just the Chinese. The Venture Capital business is one of egotistical trust in one's own ability to spot the next "Google" or "Provenge" or "tiny plumbing fragments made of metal".

Do you really think our friendly, neighborhood, anonymous VCs will simply sit around with their hands tied?

So to you I say: you should keep writing those patents, keep working in those labs, keep bootstrapping your business (look at my old posts, or talk to me if you want to know more about DIY-bio) - simply, keep at it!

Good investors, and once the bad ones have thrown their money on video game companies, there will be more good ones left than bad ones, will continue to invest in plans. They will not throw childish tantrums about reform. If the 510 (k)process takes longer, they will wait.

Why?

They know that as the entrepreneur, you will do the right things. You will plan for the delays. You will plan for the changing landscape. You will contact the FDA well ahead of time (refer to my post immediately preceding this) and set up a channel of communication. They know you will hire people focused on Bayesian methods to assess clinical trials and have an ethical stance towards the regulatory process.

They know, that the rules of the game may change, but the game remains the same - profitability and public health, not the tea party agenda.

Health Reform - Are the American Public Losers?

Unfortunately, we all tend to get carried away at various points in time. So, there are a lot of people sitting around drinking tea while the Democrats are too busy being chicken and not explaining things in perspective. Of more relevance to us, we have seen regular scenes like this play out:

1. Companies like 3M say they will stop making medical devices due to the "high" cost of reform. You can read my response to such pearls cast upon us here.

2. Companies like Caterpillar and AT&T have taken "charges" blaming health reform for their higher costs. Funny, the "charges" are actually tax benefits...

3. And now, this. Firms making "anonymous" statements about how the FDA went from being a regulatory agency to an anathema.

The magic formula

All it really takes is for entrepreneurs, investors, more importantly the pressure applying politicians (ReGen anyone?) and federal employees to be more responsible, and ethical of course.

Any business person or entity has a choice. Move with the wind, or go into oblivion...

Conclusion

It is all and well to talk about price pressures, time lags in reimbursement and how much the Americans tend to lose by being healthy (huh, you say?).

How will you feel if you went along with this song and dance and later find out that the FDA has yet again bowed to pressures and approved another sub-standard device?

How would you feel if that device was used to operate on you, or worse still left in you? Or someone you love?

How would you feel if you later found out, you have no way to recover any of your losses because of "Federal pre-emption"?

That, my dear friend, is the day you would have lost...

See, I can scare you too. It is only too easy, if you are willing to scare.

To my anonymous VC friends lurking around the dark back alleys of New England and elsewhere, let me tell you, most entrepreneurs are street smart, and in the case of medical device firms, school smart as well. If you think we are dumb enough to join you in leaving "health reform" hatred graffiti across the internet...

Reference

http://www.massdevice.com/news/local-vcs-more-worried-about-fda-moves-healthcare-reform

The Stryker Brouhaha: How the FDA demonstrates that it was never loved as a child...

If you have not heard about Stryker's (latest) legal problems, the FDA is charging Stryker and a random collection of expendable Stryker executives with off-the-label marketing.

I will link one of the many reporting stories available on the issue at the bottom, and you can read for yourself as to how, apparently, Stryker executives knowingly promoted a cement approved with stringent restrictions on marketing for humanitarian use, for off-label use. They even provided Doctors with highly suggestive recipes and concoctions on how to use the cements.

As with most of Orthopedic products that have been riddled with poor design, kickback scheme accusations and marketing attitudes, a lot of patients suffered.

So, the FDA finally jumped in!

The charges and the possible punishment

And it has accused a total of 8 Stryker folks, half of whom are classed as "former" and include, among others a former president and a sales executive.

At the outset, this all seems like "action". The charges include "wire fraud, conspiracy, misbranding, and making false statements."

Take a closer look. What does it entail as an eventual form of punishment?

Nothing, er, next to nothing in the following order: Something, Nothing, Next to Nothing.

If convicted, Stryker will face the following extremely debilitating actions taken against it:

1. As quoted: "fines for Stryker of at least $500,000 for each count"

2. "Exclusion from federal and state healthcare programs".

Okay, you read it, now say it loud with me, "Are you joking"?

Is the FDA Joking?

With you, one who is not charged by the FDA, yes.

How far does $500,000 go in 2009?

For large companies, $500,000 is chuck change. Heck, it is lesser than any of the following:

1. The amount such companies pay for their lawyers (which didn't work for Pepsi whose lazy lawyers missed a court date and are now scrambling to get a $1.2bn charge dismissed) to simply go out and harass, among others, federal agencies, smaller companies, individuals (Charles Riegel anyone?) and such.

2. The amount medical device and pharma companies pay in a quarter to lobby Congress to forget patients and pass laws that will make sure the right amounts of donations are made to individual campaign funds.

3. The amount these companies spend in a year using weak patents and other methods to harass smaller companies.

4. The amount these companies pay their executives in a month!

5. The amount that will be spent in lawyers fees defending the current charges by the FDA!!

6. The amount device companies are paying to lobby against healthcare reform of any kind!!!

And, of course I can go on and on...

This clearly demonstrates something. The FDA is obviously out of touch with reality, somewhat like a bad parent in need of love from their children at all costs.

What should be the punishment?

You may even wonder if punishment is necessary. See a lot of these brazen executives move from company to company and take their despicable attitudes with them. They do not change, because there is nothing that makes it necessary. They then proudly promulgate and breed more such "executives".

Punishment needs to be debilitating.

Punishment should invoke shame.

Large organizations thrive on corporate image across several industries. Not so in medical devices. Take Orthrocare or Stryker for example - such companies have been involved in all kinds of lawsuits. They pay cursory fines and get away with anything. Many such companies then turn around and lobby against healthcare reform!

Punishment should invoke the need for attitude change.

The punishment needs to be proportional to the crime. It is one thing for Hollywood to make disturbingly emotional movies where one soldier, one victim is important and a whole town, a whole army rallies around them.

It is another, for companies to be let go for a small fine when they kill and otherwise disable patients with obvious disregard for law and ethics.

Growing up to the times

The meter-maids, not FDA, are supposed to hand out parking tickets. Companies need to be punished proportional to their crime. Crime, among medical device companies is systemic:

1. The entire Orthopedic industry (well, the 4 companies controlling 95% of the industry) was implicated in wonderfully disgusting "kick-back schemes". Nothing came of it, except minor fines.

2. Companies like Stryker have been abhorrent at clinical research (read my squeaky hips post linked below) or at respecting patents, and systematically get involved in lawsuits. As a result of the fact that every federal agency, including the judiciary system is filled with ineptitude to mete out the right amount of judicial punishment, they keep on, keeping on.

Sending the wrong message

With the current listness and a lack of any form of seriousness, the FDA is sending the following message: As long as you hang back and reserve a few million dollars in lawyer fees and a few hundred thousand dollars in fines for the FDA, you can get away with anything you want - cooking data, promoting off-label use, anything.

At this rate, you should soon see the bigger device companies to sell 5-hour energy pills, phallic extension pills and fake weight-loss drugs.

Heck, why not? Right?

Hope and Change

If Obama and Margaret Hamburg really want change, they need to start setting examples. As I stated above, the industry does have it's fair share of fearless, lying crooks. By cowering to the fact that these companies are large and fearless, the Government is doing no better than the previous administration, and is really not bringing about any form of measurable change.

When companies such as Stryker are brought to court based on real evidence of crime, they should be made to pay. There should be no room for such companies to express "disappointed with this action and still hopes to be able to reach a fair and just resolution of this matter".

They should instead be "ashamed", rue the day they decided that bending the law was "cool", and should be forced to gouge themselves of their present attitudes.

If this is not what the Obama administration wants to do, then there will be no change, and soon the hope will whither away.

Grandma will have no insurance because that was lobbied against.

Grandma will get a squeaky hip that won't work and embarass her to no end.

Grandma will also get dysfunctional cements, stents and ICDs in her body.

And, instead of looking forward to their one hour of daily exercise, such "executives" will keep popping champaigne bottles everywhere...

References:

1. On the charges against Stryker: Click here

2. On Stryker's squeaky hips:

http://chaaraka.blogspot.com/2008/12/okay-kids-squeaky-hips-are-in-again.html

3. On Acumed Vs Stryker:

http://chaaraka.blogspot.com/2009/01/unfortunately-but-we-infringed-only.html

4. On Stryker's previous kickback settlements:

http://www.saundersblog.com/2008/01/stryker_settles_kickback_schem.html

What? The FDA and disorganized? But, how can that be...?!!

Yes, how can that be, since the Democrats, in their infinite wisdom, decided to shore up a faltering agency by dumping money and responsibility (read tobacco) on it?

What the hell am I going on about? Well, the New York Times came out with a story today about how Congressional investigators (and who exactly are these people? Are they the same ones also doling out my taxes to the FDA on the side?) have concluded that the FDA is disorganized, inept and derelict.

Don't simply say "What's new about that?" and move on.

The prelude

Apparently, aside from regulating Food, Drugs, Devices and now Tobacco (because it is food, I guess), the FDA must also punish fraudulent investigators. Now that's a tall order, especially considering that the FDA has already demonstrated unparalleled ability in the following areas:

1. Failure in the regulation of food
2. Failure in the regulation of drugs
3. Failure in the regulation of devices

In May, when the Obama administration was bringing gifts to Maryland, I lamented, along with several others on the need for the break-up of the FDA:

http://chaaraka.blogspot.com/2009/05/democrats-plan-to-fix-fda-give-them.html

Of course, no one in the Obama Administration wants to listen to you, unless you get on Fox TV and shout yourself hoarse. Some grass roots.

Anyhow, ours is not to ask, but to damn.

The problem:

The FDA is an overburdened organization with entrenched leadership. A bus load of NIH scientists and a truck load of cash will not solve the problem. Joint regulation of food, drugs, devices, tobacco, researchers and everything in-between is ridiculously infeasible.

While it is easy to make light of the FDA's failures, there is a reason why this problem happens:

1. The FDA has to take care of everyone of it's current burdens of making policy, coming up with regulations that enforce policies and rulings, report to Congress, etc.

2. The FDA has to deal with a global economy that results in devices and drugs manufactured in an an array of nations across Asia and Europe. The FDA needs to deal with fraud, counterfeit operations and GMP, GCP across the globe for anything used in the US.

3. The FDA is constantly dealing with issues and situations that have never been faced before. They need to hire and rely on outside "experts", who are usually non-existent. If they do exist, or thrust themselves in as subject matter experts, these experts usually come burdened with conflicts of interest.

All said and done, the main problem is an in-cohesive attitude towards the FDA, it's capabilities, the limitation and most of all, Congress doesn't really seem to care about action either.

While the last eight years were no party, I squarely blame the Obama administration for simply ignoring straightforward facts - the FDA is, er, "messed up".

Replacing a few embattled leaders doesn't mean much. It needs a thorough scrounging, from the inside out.

Reform the FDA

Reforming the FDA is not so tough:

1. Separate food, drug and device administrations into three separate federal organizations. Have the HHS directly, or through the CDC make sure they co-operate with each other. Or get a Czar, or a Don...whatever, just make it happen.

2. And yes, I may not be smarter than a 5th grader, but I do know that devices and drugs may sometimes be combined or classified differently. Fine - make sure that the agencies pick 50-50 on the committee for such special conditions and "deal with it". When Newton discovered gravity, people didn't run naked on the streets in shock (although, Archimedes did, well he was just crazy!)

3. Review who should be throwing "fraudulent regulators" out of business. I was a little beyond surprised to find out that the FDA was tasked with this. What about the justice department? After legalizing pot, crack, ganja, hashish, meth and moly, they do seem to have a lot of free time on their hands. Wouldn't preventing someone from doing research be something a bunch of lawyers did? Why is the FDA involved. Something is wrong here. I think even your golden retriever can see through this...

4. Do not simply pile stuff on the FDA and it's possible child organizations (if you take care of step 1, that is). It is not your once-a-week garbage truck. I cannot understand why the FTC couldn't take care of tobacco. Or maybe because it is not "food" and is directly related to "death and disease - in no particular order", why doesn't the CDC regulate this? Or maybe the HHS? I am not sure. But the FDA, to say this one more time, is not your "garbage truck".

5. More cash is not the answer. More cash means more taxes. More taxes mean more wastage. This is simply a case of divide and conquer.

6. With all the hope and change, I am sure we all got very teary eyed. Now, would be a great time to ground ourselves in reality. So, when people speak - LISTEN! If, in the course of discussions early this year, the Obama administration and/or Congress had paid any kind of attention to the clamor on splitting the FDA, all the world's Hernandezes and Campbells would now be out of a job.

Before we leave, here is some gobbledygook from the FDA as quoted by the NY Times Articles demonstrating unparalleled brain from body separation:

“The F.D.A. views any deviation from its high standards for developing or marketing drugs and devices as a potential threat to patient safety and public health,”

and

“We will take strong action against anyone who chooses to ignore or flout the legal requirements for the products we regulate.”

Especially with the last comment pasted right above, who else thinks that rolling some StarTrek credit music is in order?

"We will take strong action"

Exactly when?

Two Saturdays from never?

Watch your tax dollars rotting....

The NY Times Article:

http://www.nytimes.com/2009/10/22/health/policy/22fda.html?_r=1&ref=health

The bad workmen, er, bloggers, er, authors that blamed the tool - A tale of sidewikis and pharma.

Hey, when you cannot report actual news, you can simply make something up right? Even if it is not remotely connected? Even if you are attacking the wrong problem or providing the wrong suggestions?

So, I have decided to take the plunge as well. See, we are now on a 24 hour news cycle. Everyone needs to be yelling, yelping, blogging, vlogging, twittering, facebooking, other-anatomical-region-book-ing, and what not.

When there are no new protests to protect "innovation" (read old wine in new stents bottles), or no new articles that Merck never wrote, or no new medical device company "consultants" to write about...

Well, you make something up.

And so is born the great panic of 2012, er, "Sidewiki"!!!

Sidewiki

According to Google, "Google Sidewiki is a browser sidebar that lets you contribute and read information alongside any web page."

In an effort to take on the wikipedias of the world (hey, I can create panic too!), Google has created a tool that can run alongside IE and Firefox 2+ and allows you to add your own mis-truths, truthinesses, truthisms and possibly a few facts to web pages.

This will allow you to go on your favorite (or not) Pharma/Med Device Company's (or any other website for that matter) and leave notes about exactly what you think of them. You can also get creative and leave pieces of your mind as well. And other stick-yer-nose-where-it-don't-belongers sidewiki users can join you in further glorifying these websites with their own colorful interpretations.

Pharma Companies, FDA and the manufacture of news

Now, let's make that into news.

How?

1. Sidewiki is this evil tool that allows the evil patients suffering from mild side-effects of drugs and devices such as permanent disability, blindness, cancer etc., get a chance to go to the websites of the companies that defrauded and/or hid data, or never cared enough to perform studies on the cheap plumbing, I mean stents they make, or companies that made their hips squeak - and spew venom!

2. Sidewiki is also this charming, deceptive tool that will suddenly convert well-meaning, trained marketing folks who have hitherto shown such unparalleled levels of responsibility, to suddenly go on their own companies' sidewiki sites and exaggerate claims of what the devices and drugs can do.

3. The FDA, which is currently well equipped and is doing such an excellent job of regulating itself and the growing list of industries ranging from tobacco to drugs and food, being regulated under it's able command will suddenly loose direction and debilitated and miss out on just this one aspect - the regulation of pharma companies and how they interact on sidewikis!

Should we treat the symptom or the disease?

Wait you say. Isn't it possible for the genius marketing weasels to go and cook things up on the sidewiki and get their companies in trouble? Or for all these patients to go write about what happened to them and prevent these wonderful ineffective drugs and devices from making their investors stinking rich?

Well, yeah. The answer is in the famous words of the pithy cliche, "Your bathtub is overflowing, do you clear the water first or turn off the faucet first?"

Let's look at both possibilities:

You see, inappropriately trained employees who are told to take a laissez-faire attitude on ethics - marketing personnel, telemarketers, bloggers, Presidents, Fox News Reporters and even the unicorns could end up doing the wrong thing.

Merck did it with the fake publications...

Glaxo did it by hiding the news of Avandia..

Then there were Celebrex, Vioxx and Yaz...

The FDA and Congress with the knee implant approvals..

The Obama Administration's "tort reform" with it's misplaced and unfruitful love for "bipartisanship". (Well, then why not simply embrace Fox News? That would be one hell of a bipartisan move. Equally useless, but definitely bipartisan!)

You see, irresponsibility is omnipotent - the medium is not the problem.

The "new headache" that you will read about in the articles I will link below, are after all, not new headaches. If people decided to be ethical and make it policy, at the macro-level, not with individual policies for twitter and Facebook, then the problem is solvable.

A matter of shame

Being regulated and chastised by the FDA for ethical failures should be seen as a matter of shame by the company, not a bright, bubbly, cheerful "You might have recently seen some Yaz commercials that may have been misleading. The FDA, weak, useless and unable to actually do anything by way of real punishment, has asked us to further confuse you idiots.."

Only a bad workman or blogger blames his/her or someone else's tools. Others, try to keep going back to the central theme - the state of the industry, as it is, should have never come to exist.

There is still time to fix it.

Companies can still choose right against wrong.

Now, to the second issue:

Don't fight disgruntled patients and bloggers

Man up! There is bad news about you because YOU covered something up. You released the stent without ever bothering to find out if it worked. You knew your diabetes drug was causing heart attacks. You threw in Doctors' names when they did not even touch the publication. You paid people to "consult" and concoct data for you. You and your Congressman forced the approval of a dysfunctional device. You approved the device...

YOU are the problem. Not dead and dying patients.

Exhort that - don't simply look to score random, nonsensical brownie points dissing sidewiki or facebook.

Links to a couple of articles:

Story 1

Story 2

If you decide that you don't care much for ethics, then maybe Las Vegas is the place for you, not the pharmaceutical industry. It doesn't matter if you are manufacturing or "reporting".