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‘Scary World’ of Generic Drug Manufacturing, Revealed (copied from Medscape)

Ellie Kincaid

June 06, 2019

In 2008, investigative journalist Katherine Eban started digging into the generic drug industry after hearing stories of patients whose generic drugs were not working properly for them. They had been stable on a branded drug, but then relapsed once switched to a generic version or experienced troubling side effects when switched between generics. She detailed her findings in a series of articles in the magazines Self and Fortune, and her new book, Bottle of Lies .

Katherine Eban. Robert Falck

The majority of generic drugs are manufactured overseas, and “the [US Food and Drug Administration] FDA was essentially regulating on an honor system,” Eban told Medscape Medical News. The agency would announce its inspections of overseas manufacturing plants weeks or months in advance, giving companies an opportunity to prepare to put on a good face and mislead inspectors with fabricated data.

In the course of Eban’s reporting, she obtained 20,000 internal FDA documents that “revealed that the FDA’s investigators have grave doubts about the quality of the drugs being manufactured at these plants,” she said. But FDA officials minimized the investigators’ findings.

Eban spoke with Medscape Medical News about the implications of her findings for clinicians. The following is a lightly edited account of the conversation.

William Rassman’s Comments: Many readers have told me that they felt that their Generic Finasteride was not as good as the Proscar when cut into quarters. Proscar is a drug manufactured by Merck and it is reasonably priced for hair use and if you have such a concern, then getting your doctor to prescribe Proscar is a reasonable way to address your concerns.


2019-06-10 18:19:09‘Scary World’ of Generic Drug Manufacturing, Revealed (copied from Medscape)

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Scars from FUE (Photo)

Scarring from FUE is common. If it bothers you, the best treatment is Scalp Micropigmentation. I don’t know how many grafts you received, but if it exceeded 3,500 FUE grafts, it is likely that you were over-harvested. We have performed SMP on many people with all types of donor scars including for FUE, see here: https://scalpmicropigmentation.com/scar-covering/

fue scarring

 

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Scars from Strip Harvesting Surgery

I have a terrible scar from a previous hair transplant in the donor area. What can be done about it?

If you find that you have a scar from your donor harvest that you find is unacceptable, these options need to be discussed with a competent doctor. The scar often has ridging from the nature of the closure and that will be determined by the doctor who evaluates you. Scars from the donor area are not uncommon and when the surgery is done by a competent surgeon doing standard of care work, scars may still form and be the result of the way your body heals. The treatment of scars are as follows:

  1. Do nothing
  2. Perform a scar revision with a surgeon who can do trichophytic repairs and use ACell in the wound to give you the best opportunity to heal it.
  3. Have FUE into the scar. This can fill in the scar, but hair direction may not be controlled by the surgeon, making the results often disappointing. Two sessions into the scar may be needed.
  4. The use of Scalp Pigmentation has been a significant breakthrough in our hands. Risks include change of color (unusual for the back of the head where hair covers the pigmented area protecting it from the sun). This will not address any ridging in the scar area.
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Scars from hair transplant

I got an FUT 3 years ago. My scar unfortunately is “raised” and wider than expected. I’m not sure if it just healed wrong, or surgeon error. I was originally told my hair would need to be cut to a “5” for it to be unnoticeable, but it takes more like an “8” or “9”. I use dermatch or fibers to cover it with shorter hair.

A few months ago, I decided to get SMP on it. I had 5 sessions, and the ink just didn’t stick at all. The practitioner said it was due to the scar being “raised”. This was a couple thousand dollars, so I’m not feeling great about it.

Should I have something done to the scar before attempting something like SMP again? What about grafting some hairs into the scar? I’m not sure if my scar is hypertrophic, a keloid, or what. I just don’t want to spend more money on something that won’t work.

We treat raised scars with Kenalog injections which flatten then out (sometimes it takes a few months and more than one injection). Then I do the SMP into normal scars. See here: https://scalpmicropigmentation.com/gallery/scar-covering/


2020-09-04 12:34:15Scars from hair transplant

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Scars from FUE

I may have heredity loss or loss as the result of medication. I just wanted to confirm that the Fox procedure does leave tiny scars at the donor area (where the hair is taken from)? Also, does the fox procedure also leave tiny scars where the hair is implanted. Please review and let me know of your thoughts.
Thanks in advance

1 Year After FUE – Parted 1 Year After FUE – Shaved

 

At the point where the follicular units are removed, there may be small punctate scars, but not at the recipient site, as the skin is trimmed once the grafts are outside the body. The skin disc that was removed in the FUE from the above photo were created by a 1mm punch, today the punch size measures 0.9mm. Trimming of the excised FUE grafts are critical to minimizing the transplantation of skin for the recipient area, which is clearly not the objective. When these FUE grafts are trimmed, the skin disc is reduced to 0.1-0.2mm in size, thereby minimizing scars at the recipient site.

For more on FUE / FOX Procedure, please see:


2006-10-04 16:26:47Scars from FUE

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Scarring from necrosis in the donor area secondary to poor FUE (photo)

This patient had too many FUEs performed too close and possibly with instruments that were too large for the process. Necrosis (skin death) is a complication seen in the inexperienced, over ambitious hands of inexperienced doctors or technicians who should not be doing FUE. I expect this complication to be more and more common in the coming years and more and more providers enter the FUE business without adequate training. The only tre)atment for this is Scalp Micropigmentation, which will work well provided that the patient keeps his hair very short (see: https://scalpmicropigmentation.com/scar-covering/

scarring from necrosis

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Scarring from FUE – Why Does It Happen and What Can I Do About It?

The scarring is related to the size of the instrument used by your doctor. When the punch is 0.9mm or less, the scars are less prominent. If you have scars as some people do, regardless of the surgical technique, then Scalp Micropigmentation is a solution to “wipe” them out visually. We do this all of the time for people who had an FUE procedure.

Hair transplant FUE scarring from tressless


2018-08-15 08:58:58Scarring from FUE – Why Does It Happen and What Can I Do About It?

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Scarring alopecia following a hair transplant

I was just told (from another doctor) that one of his patients who had two hair transplants surgeries totaling 5500 grafts, got a third hair transplant and then lost all of the previous hair transplants. The third hair transplant did not grow. A biopsy was done and the diagnosis of Scarring Alopecia was made which clearly caused the loss of the hair. This is an autoimmune process. Of course, the patient was concerned that the scarring alopecia risk was risk he was told about and the patient was angry. This is the very first time I heard about the appearance of a Scarring Alopecia after a hair transplant. I am not certain that there is a one-to-one- correlation between the last hair transplant and the appearance of the scarring alopecia, although the incidence is highly suggestive of it.

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Scarless Healing from New Drug Called Juvista?

Hello Again Mr.& Dr.Rassman

We’re all in here thanking you for your salvation blog as am now going thru it on a daily basis.

I’ve this Revolutionary News for you which might be the long awaited Deliverence to many of us who have had Traditional Strip HT & left with a linear thin scar(hopefully) in the back making us feel so confined. Have you ever heard of a new innovative drug being developed by ”Renovo plc.” so called ”Juvista”, as mentioned it’s now in the PhaseII clinical trial & might see the light in the few coming years. It’s basically used during the surgery by being injected to the wound edges while suturing(i think) which will later lead to an almost scareless healing (GOD I HOPE THIS GONNA HAPPEN), please comment.

Juvista consists of recombinant TGFβ3. TGFβ3 is present at high levels in developing embryonic skin and in embryonic wounds that heal with no scar, but by contrast, is present at low levels in adult wounds that scar. Since the FDA has not approved of this drug yet and it still is in clinical trials, I will not comment much until further studies have been published. To get this drug to be approved by the FDA may take many years. In the mean time, please take a look at Techniques to Minimize Donor Area Scarring, which shows the modern techniques employed today (deep fascia closure and trichophytic incisions).

You can read more about Juvista here.


2006-04-17 15:02:25Scarless Healing from New Drug Called Juvista?