WARNING: LONG BUT IMPORTANT POST.

Hey guys,

Over the years I've had more patients than I care to count ask me about this product or that product and what I know about it and it's ability to grow hair. You all know what I'm talking about; the different herbs, extracts, shampoos, lotions, cattle prods, etc. I usually say something regarding the marketing of these products (page 16D of your local paper or in the back of Maxim magazine) and whether or not they are discussed on the nightly news or if it's in Time magazine. In other words, if there is something to it, you'd hear about it like Propecia and Rogaine when they came out. Both announcements were big news. While Propecia and Rogaine are effective to different degrees they both have one thing in common...they are both approved by the FDA which in and of itself speaks volumes. Well, that does not appear to be the case so much anymore.

A new product is on the market. Well, it has been for years actually but it's place in this field has just risen dramatically because of two reasons. It's in the news, big time, and it's recently gained FDA approval. After reading about it with quite a bit of interest I decided to do some reading. Out comes the laptop and the ever trusty Google homepage. This is what I have learned.

I found a lot of useless information about catheters and diabetes treatments but then I found what I was looking for.

This first paragraph leads into my original reason for inquiry.

"The process of drug development and approval by the United States Food and Drug Administration (FDA) was recently reviewed by Lipsky and Sharp.[1] Using clinical literature and web sites addressing FDA procedures, that review concisely described the FDA's history, the official approval process, and recent developments in drug approval. However, it did not delve into common misconceptions about the FDA, tensions within the agency, or conflicts of interest in the drug approval process. The rapidly growing business of medical device development, distinct from the drug approval process, also was not addressed. Although most aspects of the FDA review process are highly successful, its limitations deserve careful consideration, because they may have important implications for choosing treatments in practice."

That last sentence means more than you know.

"For high-risk devices, demonstration of safety and efficacy are also required. But for moderate risk devices, only safety and "substantial equivalence" to a previously marketed device are required. The benefit of a new drug or device must be judged to outweigh the risks. This is all Congress has allowed the FDA to require."

This means that a moderate risk device can just sit there and do nothing but if it doesn't cause your liver to melt then it's ok. "Substantial equivalence"? Remember this term.

"Common Misconceptions" about the FDA

"Drug approval generally requires rigorous testing of clinical efficacy, in the form of at least 2 randomized controlled trials. However, the regulations for medical devices are quite different. Medical devices include anything from contact lenses to cardiac pacemakers and MRI scanners. Most new devices are approved by demonstrating "substantial equivalence" to a product that was marketed more than 25 years ago (before 1976). For this type of approval, a device need only do technically what it claims and be reasonably safe. A device that delivers electric current to the skin can be considered "effective" without asking if it relieves symptoms. Devices that do not claim substantial equivalence to an older device (a tiny fraction of new submissions) are required to undergo more rigorous review. This may or may not require randomized trials."

So medications do receive plenty of scrutiny but some medical devices do not. More on the types of devices and their classifications are to follow.

Things the FDA Does Not Do

"There are some potentially valuable functions the FDA does not perform. For example, it does not approve old drugs and devices. Some medical products in wide use were marketed before FDA approval was required, and their use is "grandfathered" in.

This is big. Nothing on the market before 1976 was actually tested to even be safe, much less effective, by the government. All we had to rely on was the manufacturers' claims.


Medical Devices"

The FDA's approach to approving medical devices differs substantially from the approach to drugs, being in some ways both more complex and less stringent.[13] The FDA's authority over devices dates only to 1976. Device legislation was a response, in part, to public outcry over some well-publicized device failures. The most prominent was the Dalkon Shield—an intrauterine contraceptive device associated with serious infections.[14] In contrast, the FDA's authority over drugs dates to 1938, although it existed in weaker form starting in 1906.[15]

With few exceptions, given the timing of the FDA's authority, devices introduced before 1976 were never required to undergo rigorous evaluation of safety and efficacy. With the huge volume of "things" that suddenly fell under its purview, the FDA had to prioritize its resources and efforts.

One way of prioritizing was to focus first on safety. Evaluation of effectiveness, in many cases, was reduced to engineering performance: does the device hold up under its intended uses, does it deliver an electric current as advertised? The potential benefits for relieving pain, improving function, or ameliorating disease did not generally have to be demonstrated.



"...did not generally have to be demonstrated". Something to seriously think about. These last few paragraphs above basically say that a device is not necessarily evaluated for how effective it is (does it do what it claims to do) but rather it's safety (will it make the consumer's head fall off, arms explode, etc.) The next bit of the article goes on to describe the levels of scutiny that devices undergo with reference to mundane devices such as latex gloves. These levels are referred to as Class I, Class II, and Class III with Class I being q-tips and Class III being artificial heart valves and other high risks devices.

Class II is what caught my eye.

"Class II devices are perhaps the most interesting. They comprise an intermediate group, generally requiring only performance standards. Examples would be biopsy forceps, surgical lasers, and some hip prostheses. The performance standards focus on the engineering characteristics of the device: does it deliver an electrical stimulus if it claims to, and is it in a safe range? Is it made of noncorrosive materials? Most of these devices get approved by the "510(k)" mechanism. The 510(k) approval requires demonstrating "substantial equivalence" to a device marketed before 1976. "And," says Kessler, "the products that have been pushed through 510(k) are astonishing" (L. Kessler, personal communication)."

You may be wondering who L. Kessler is that was just quoted in the above paragraph. He works for the FDA.

Here is more...

"Kessler points out, "For the first 5 to 10 years after 1976, this approach made sense. But in 2001, 25 years after the Medical Device Amendment, does it make sense? There was a lot of stuff on the market that wasn't necessarily great in 1975—why would you put it back on the market now?" (L. Kessler, personal communication). The new device need not prove superiority to the older product—just functional equivalence. If a company wants to tout a new device as a breakthrough, why would it claim substantial equivalence to something 25 years old?

The reason is that the 510(k) process is easier and cheaper than seeking a premarket approval. The 510(k) process usually does not require clinical research. In the mid-1990s, a 510(k) application on average required 3 months for approval, and about $13 million. A premarket approval required, on average, about a year and $36 million. Both are modest compared with new drug approvals. The process by which the agency decides if something is "equivalent enough" to be approved by the 501(k) mechanism is subjective.

Because pre-1976 devices were not subject to any rigorous tests of clinical effectiveness, a newly approved device may be equivalent to something that has little or no therapeutic value. Doctors, patients, and payers therefore often have little ability to judge the value of new devices. As an example, the FDA still receives 510(k) applications for intermittent positive pressure breathing machines.[12] Yet a thorough review by the federal Agency for Health Care Policy and Research found that these devices offer no important benefits.[16]

How much do manufacturers take advantage of the easier 510(k) approach? Since 1976, nearly 98% of new devices entering the market in class II or III have been approved through the 510(k) process.[13] In 2002, the FDA reported 41 premarket approvals and 3708 approvals through the 510(k) process.[17]"

What is pre-market approval? Basically, it is the process that a device must undergo when there is no significant equivalent that was in the market place before May 28th, 1976. It is a fresh product that must not only be proven safe but also EFFECTIVE.

So, to summarize the above, medical devices that are rated as Class II by the FDA do not necessarily have to show that they perform as advertised, only that they are safe. Remember that term I asked you to keep in mind, "substantial equivalence"? The FDA only started to regulate medical devices on May 28th, 1976 under the Medical Device Amendment. Medical devices that were on the market before this date were grandfathered in. Any medical device put into the market place after this date can be approved by the FDA if it has qualified as a "substantial equivalent" to a device that was similar and grandfathered in. They have to have basically the same components, therefore making them not so new, with no real review process to see if it actually does what it is marketed to do. Manufacturers can say they have conducted performance studies and they can even submit them along with their FDA application (and millions of dollars) but the FDA does not necessarily use these "studies" in their approval process.

With all the products that we patients (remember that I'm a patient too) have to weigh and judge to find one that works we do not need a new level of complexity to navigate to avoid the release of our hard earned dollars for products that will kill your plants or double as set props on a Star Trek episode. Consider what I have presented to you with great care. I have posted this because I want to protect my balding brethren. Remember that what I have presented does not necessarily mean that a device will not work as advertised but that "FDA Approved" may not mean what you think it means.

Think, learn, apply.

SWEET!

That is awesome. I stick to my belief about the LASERCOMB.. I'm would assume it is safe but not effective..

Joe,

Great post, I am with Jobi on this lasercomb stuff, for that matter minox and fin are not wonder drugs either. Get a HT, its the only permanent solution.

I have never had any faith in the FDA. Too any opportunties for payoffs.

Joe,

Your "watchdog" style commitment to the HT industry is outstanding, my friend. Thanks so much for taking the time to do this invaluable research. Just because something is "FDA approved" doesn't mean it's going to provide the results claimed by the producer.

All the more reason we need to SEE the results to back up any claim!! Great stuff!

Joe,

This is excellent information and research on your part. I've always had concerns about the way the laser comb in particular has been marketed. Their recent information (more like media blitz) did give the impression that like Rogaine and Propecia, their laser comb was FDA approved based on its effectiveness.

According to your information they have really leveraged a very lame FDA approval into a false marketing endorsement.

I didn't realize what a joke the FDA was when it came to approving devices. How silly that you can approve current devices based on their similarity to devices that were grandfathered in because the FDA didn't have the resources to evaluate them.

With your permission I'd like to include the real story about the Laser Comb's "FDA Approval" on our community blog and newsletter.

I'd also like to email this information to all the physicians on the HTN.

Thanks for your extensive investigative work on this.

Pat

Fellas, remember that the FDA is a very important necessity as it still does a great deal to protect us with regards to foods and drugs but the key is to know how they work. There are a lot of issues that could be improved. For instance, the majority of it's funding comes from the fees received by the manufacturers when they submit a product for review which some say is a conflict of interest. The FDA should be funded entirely by the government which unfortunately means us the taxpayers but in this case I'd be happier knowing that there is not any money from one particular manufacturer that could influence any decision making.

More than anything though the Medical Device Ammendment should be changed so that devices receive the same scrutiny as medications and foods.

Another thing that people should know is who is behind some of the devices on the market now. One device has on it's "advisory board" a gentleman that is behind the marketing machine of a very well known hair transplant chain that airs infomercials on late night television.

Pat, it's not for me to say whether or not you can use this because it is in the public domain on the web and is available to anyone and everyone. One just needs to know what to look for or what questions to ask. Use it how you will but it is something that everyone should know so they are more informed when they make their decisions. This is especially important when it comes to the hair loss industry.

Thank you for having an outlet for this information to be shared.

Think, Learn, Apply

Jotronic you are a wealth of information, and I know helping others with hair loss is your passion. Keep up the good work, and thank you.

Joe,

Commendable post my friend and very informative. I definitely learned a lot about the FDA that I did NOT know from this post. Recently, though not often, for rare cases, especially in women, i have recommended that they try the lasercomb to see if it does anything for them. I admitted to them that I have not done extensive research on it but that the FDA approved it. I had no idea (it being a medical device and older) that it's approval was based solely on safety rather than safety AND effectiveness.

There are some doctors that swear by it and have some research to backup the claim that it can work...however it's good to know what exactly FDA approval is not only for this product, but now understanding how it works for any product they approve. Obviously, effectiveness is part of what they evaluate in some cases, but clearly not others...which I think is a problem and feel that should be changed. FDA approval for the laser technology gives false hope to those who feel that it should be considered equal with Propecia and Minoxodil. I suppose more conclusive research is needed regarding effectiveness for laser technology. So I'd say I stand somewhere in the middle...I am not going to discount that there MIGHT be some purpose...but I admit I don't have enough knowledge of the research to validate any claim made by it.

Thanks again for the info my friend!

Falc

Falceros,

As long as my post made you think, then my mission was accomplished.

Joe,

Well done my friend, well done!

Falc

That was an excellent post. One of the very best I've ever read on a forum. Funny too.

I have several 510k s to my name for medical devices I've designed and built over the years. While it was certainly convenient and cheap to get approval on my devices using the "substantial equivalence" argument, it is true that there is room for abuse. Laser combs are only a SMALL example of this abuse.

Keep in mind, however, that the 510k process also allows good and useful products to receive approval much faster than without it.

I was never a fan of gov't regulation because it provides a false sense of security to the general public and makes them become lazy about researching products and thinking for themselves. How else could a product like laser combs not be laughed off the market? By "approving" the product the gov't has given the public the false perception that it has consistent and demonstrable efficacy.

Forum viewers and contributors are obvious exceptions to this rule. Gov't intrusion into invention and development styfles innovation.

It seems there will always be a good and bad side to every process. For this reason, it is up to the public to be EVER vigilant when opting for anything medical or otherwise. A good place to start is common sense. If what is being offered seems too good to be true...then it is!
The second place to start is to examine the credibility of those offering the "fantastic product". If they seem like sleezy salespeople, then step back and re-evaluate.

quote:

For this reason, it is up to the public to be EVER vigilant when opting for anything medical or otherwise

How does the public do this Dr. Feller? What you suggest is virtually impossible. The public cannot submit products to blind studies and peer review to determine if a product is safe or not, effective or not. Only the government is well suited for that role, and the FDA has again and again let the public down. Not only does it approve medical devices which should never be approved (who knows how many people will waste their money on these lasers), but it approves drugs that actually kill - Vioxx comes to mind. Heck, the FDA has the public believing that generics are always the exact equivalent to the brand drug, and that is sometimes not true. Sometimes not even close. Just my two cents for the evening.

Hoping

I think what Dr. Feller means here is to know all the facts before YOU - part of the public - take the leap forward. This is the same advice we give here all the time regarding hair transplantation. Research and educate yourself. The more you know, the more you can make an informed decision.

Think of a resarch paper or thesis. One always had to consult a number of sources to become properly informed in order to make or prove a point.

The FDA is just one source. Of course, extensive research into 510k approval shows what Joe has already posted above. HOWEVER, other sources need to be consulted to get the bigger picture.

Proceed into anything with knowledge and wisdom. The only way to do that is by educating yourself first, despite any hype that you might hear.

Falc