Dr. Peppa

Doctor Mike vs. Dr. Alex Tatem on the FDA peptide vote: we checked the documents

Published by Dr. Peppa ·

Split-screen graphic: Doctor Mike on the left and Dr. Alex Tatem on the right, with 'VS' between them
Doctor Mike (left) and Dr. Alex Tatem (right). Images from their YouTube videos.

Disclosure: Dr. Peppa is owned and operated by Medtruva LLC, which sells peptide products, including some compounds discussed on this site. Advertisements are labeled.

The quick version

  • In July, an FDA advisory committee voted to recommend six of seven peptides for a list that lets pharmacies compound them. FDA's own reviewers had recommended against all seven.
  • Doctor Mike argued the vote was driven by newly appointed members with industry ties. The FDA roster and the reported vote counts back his core point.
  • Dr. Alex Tatem argued Doctor Mike misdescribed the law. The regulation text backs Tatem on that. Several of Tatem's own supporting details don't hold up.
  • Neither the vote nor the list is FDA approval. Both doctors say so.

The two videos

On September 9, Mikhail Varshavski, DO, who posts as Doctor Mike to about 15 million subscribers, published Exposing The Truth About Peptides. It passed 6.8 million views within a week.

On September 16, Alex Tatem, MD, a urologist with about 257,000 subscribers, published a point-by-point response titled Doctor Mike LIED About Peptides.

Tatem disclosed his position at the start of his video. He prescribes peptides, has used them himself, sits on an unpaid advisory board for a peptide-medicine professional group, and testified at the FDA meeting both videos discuss.

Doctor Mike said in his video that he would discuss and promote a peptide if it were shown to work for a specific use and had an established safety profile.

Both videos are about the same event, so that's where we start.

What the committee was actually deciding

On July 23 and 24, 2026, FDA's Pharmacy Compounding Advisory Committee (PCAC) met to consider seven peptides: BPC-157, KPV, TB-500, MOTS-c, emideltide, epitalon and semax.

The question was not whether FDA should approve any of them. It was whether they should go on the 503A bulks list, which names ingredients that licensed pharmacies may use to compound medications for individual patients even though the ingredient isn't part of an approved drug.

The committee's vote is advisory. FDA's meeting page says advisory committees "make non-binding recommendations to the FDA." Adding anything to the list still requires formal rulemaking with public comment.

Both doctors agree on this. Anyone telling you a peptide is now "FDA approved" because of this meeting is wrong.

Claim by claim

1. Did the vote "slide under the radar"?

Doctor Mike opened by describing the vote as a story that had slipped past nearly everyone.

Tatem said it was widely covered, heavily commented on and livestreamed.

What we found: The meeting was broadcast live on YouTube, and FDA's meeting page links the recording. NPR, CNN, The Hill and Associated Press wire stories covered the committee before and after the vote. A law firm tracking the docket reported roughly 1,860 public comments before the meeting.

Verdict: Tatem is right. It was a covered story. It may not have reached most of Doctor Mike's audience, but it wasn't hidden.

2. Is the bulks list a "new shortcut" that skips proof of effectiveness?

Doctor Mike described what was unfolding as a potentially new and dangerous shortcut, one that could let experimental substances reach patients without proving safety, efficacy and quality.

Tatem said the law was written this way on purpose and has been for decades.

What we found: The four criteria are in federal regulation, 21 CFR 216.23(c). The third one reads:

"The available evidence of the effectiveness or lack of effectiveness of a drug product compounded with the substance, if any such evidence exists"

FDA's 2019 rule describes the evaluation as a "consideration and balancing of the four criteria." FDA's own briefing for this meeting repeats that it "will use a balancing test."

The framework is not new. Section 503A was added by the Food and Drug Administration Modernization Act of 1997, and Congress revised it in 2013.

Verdict: Tatem is right about the law. Effectiveness evidence is weighed where it exists, and it is one factor among four, not a requirement. The pathway is about 30 years old.

Doctor Mike's underlying concern is a policy argument, not a legal claim, and it's a fair one to debate. His worry is that consumer demand could stand in for clinical evidence. It's also worth noting that Doctor Mike himself said in the same video that the bulks list is not FDA approval.

3. Is there really no human data on KPV, TB-500 and MOTS-c?

Doctor Mike said FDA's scientists could not find human exposure data for KPV, TB-500 or MOTS-c.

Tatem said that finding was narrower than it sounds, and pointed to human studies of related molecules.

What we found: FDA's briefing documents say what Doctor Mike said they say.

Tatem's counterexamples are real studies, but they are studies of different molecules:

On BPC-157, Doctor Mike said FDA found one small human study relevant to the nominated use, a conference abstract with 53 participants in which it was given as an enema. That's accurate. The briefing lists a handful of other small clinical reports for other uses, and FDA found no clinical studies of BPC-157 for tendon or muscle injuries.

Verdict: Doctor Mike accurately described FDA's findings. Tatem is right that related molecules have been tested in people. But data on a related molecule isn't data on the substance that was nominated, and FDA says so explicitly.

4. Who voted yes?

Doctor Mike said eight of the committee's eleven regular voting members were new, that many had ties to clinics or compounding businesses, and that every yes vote came from that group.

Tatem said the committee also included eight temporary academic members added for this meeting, that all of them voted no, and that the picture of a stacked panel left them out.

What we found: FDA's published roster lists 11 regular voting members.

The roster also lists eight temporary voting members from Weill Cornell, USC, Georgetown, Stony Brook, the University of Pittsburgh and the VA, plus a patient representative and a consumer representative. But most were seated only for specific compounds, so no single vote had more than 15 people voting.

Reported tallies (FDA hasn't posted official minutes yet):

Peptide Yes No Abstain Result
BPC-157 8 6 1 Recommended
KPV 8 6 1 Recommended
TB-500 8 6 1 Recommended
MOTS-c 7 5 2 Recommended
Emideltide 6 7 1 Not recommended
Epitalon 7 4 1 Recommended
Semax 8 5 1 Recommended

NBC News reported that on BPC-157, KPV and TB-500, "all eight of the new appointees voted yes." With 8 yes votes in total, that means every yes vote on those three came from the new members.

The no votes did not come only from temporary members. Pre-existing regular members also voted no. On emideltide, one of the new members voted no too.

Verdict: Doctor Mike's core claim holds up. The yes votes on the headline peptides came entirely from the eight new appointees. Tatem is right that academic members were in the room and that Doctor Mike didn't mention them. His claim that all of them voted no isn't supported by the reporting we found.

5. What about Marty Makary?

Doctor Mike said FDA officials, including then-commissioner Marty Makary, reportedly raised conflict concerns about the new members, HHS went ahead anyway, and Makary "later" resigned under pressure.

Tatem said Makary resigned on May 12 over a dispute about flavored vapes, weeks before the panel was announced, so "later" gets the order backwards.

What we found:

Verdict: Split. Tatem is right that the resignation came before the panel was announced. Doctor Mike's "later" is misleading. But Tatem's claim that it had nothing to do with peptides goes further than the reporting supports. Whether Makary personally objected is unconfirmed.

6. The 2023 restrictions and the lawsuit

Doctor Mike said FDA identified significant safety concerns with many compounded peptides in 2023.

Tatem said FDA had no evidence behind those concerns, declined to defend them in court, and settled a lawsuit in a way that produced this meeting.

What we found:

Verdict: Tatem's version doesn't match the court record. The case was real and it did lead to committee review, but of other peptides, and without the admission he described.

7. The thalidomide comparison

Doctor Mike ended by recalling that FDA reviewer Frances Kelsey kept thalidomide off the US market.

Tatem said that happened through the new-drug approval process, which has nothing to do with the bulks list.

What we found: Both statements are accurate. FDA's own history page credits Kelsey with keeping thalidomide off the US market. It was a new-drug application, a separate process from compounding.

Verdict: Both are factually right. Whether the comparison is fair is a judgment call. Doctor Mike used it to argue for regulatory caution in general, not to say the two processes are the same.

Where they agree

Once you set aside the tone, the two videos overlap more than their titles suggest.

The disagreement is mostly about two things. The first is whether the law makes this pathway reasonable or reckless. The second is whether the new committee members were a legitimate voice for clinicians or a conflicted majority.

What we still don't know

The bottom line

On the evidence, Doctor Mike described FDA's findings accurately. On the law, Tatem described the regulation more accurately. Both made errors of detail, and Tatem's lawsuit account is the biggest factual miss in either video.

If you watched only one of these videos, you got half the picture.

The fact-check scorecard

Seven disputed claims, each checked against primary documents. Details and sources for every verdict are in the sections above.

Who got it right?
Doctor Mike421
Dr. Alex Tatem331

  1. 1. Was the vote under the radar?

    Doctor Mike

    The FDA peptide vote slid under almost everyone's radar.

    ✗False

    NPR, CNN, The Hill and AP wire stories covered it, and it was livestreamed.

    Dr. Alex Tatem

    The vote was widely covered and livestreamed.

    ✓True

    Confirmed by FDA's meeting page and news coverage.

  2. 2. Is the bulks list a new shortcut?

    Doctor Mike

    It's a new shortcut that lets substances skip proving they work.

    ~Partly true

    Effectiveness evidence isn't required. But the pathway dates to 1997, and it isn't FDA approval.

    Dr. Alex Tatem

    The law weighs effectiveness only "if any such evidence exists," and it's decades old.

    ✓True

    That's the text of 21 CFR 216.23(c).

  3. 3. Is there human data?

    Doctor Mike

    FDA found no human exposure data for KPV, TB-500 or MOTS-c.

    ✓True

    FDA's briefing documents say exactly that.

    Dr. Alex Tatem

    These compounds have meaningful human research behind them.

    ~Partly true

    The studies are real, but of related molecules. FDA says thymosin beta-4 and TB-500 are not the same substance. Some figures were off.

  4. 4. Who voted yes?

    Doctor Mike

    Every yes vote on BPC-157, KPV and TB-500 came from the eight new members.

    ✓True

    Reported by NBC News, consistent with FDA's roster.

    Dr. Alex Tatem

    Eight temporary academic members were also voting, and all voted no.

    ~Partly true

    They were there, mostly seated only for specific compounds. Pre-existing members also voted no.

  5. 5. Marty Makary

    Doctor Mike

    Makary raised conflict concerns about the panel and later resigned under pressure.

    ~Partly true

    FDA officials reportedly raised concerns, but not confirmed as Makary personally. He resigned before the panel was announced.

    Dr. Alex Tatem

    Makary resigned May 12 over flavored vapes, which had nothing to do with peptides.

    ~Partly true

    The date is right. NBC reported the pressure wasn't limited to the vape dispute.

  6. 6. The 2023 restrictions

    Doctor Mike

    In 2023, FDA flagged safety concerns with many compounded peptides.

    ✓True

    FDA listed them as substances that "may present significant safety risks," mostly citing missing data.

    Dr. Alex Tatem

    FDA settled a lawsuit, admitted it had no evidence, and that led to this meeting.

    ✗False

    The case covered four other peptides, and the court record shows no such admission.

  7. 7. Thalidomide

    Doctor Mike

    FDA reviewer Frances Kelsey kept thalidomide off the US market.

    ✓True

    Confirmed by FDA's history office.

    Dr. Alex Tatem

    That happened through new-drug approval, a different process from the bulks list.

    ✓True

    Thalidomide went through a new drug application.

Sources

Videos

Law and FDA records

Studies

Reporting