It’s hard for me to believe that it’s been almost three years since I first started taking an interest in the Houston cancer doctor and Polish expat Stanislaw Burzynski. Three long years, but that’s less than one-twelfth the time that Burzynski has been actually been administering an unproven cancer treatment known as antineoplastons (ANPs), a drug that has not been FDA-approved, to patients, which he began doing in 1977. Yes, back when Burzynski got started administering ANPs to patients, I was just entering high school, the Internet as we know it did not exist yet, just a much smaller precursor, and disco ruled the music charts. It’s even harder for me to believe, given the way that Burzynski abuses clinical trial ethics and science, that I hadn’t paid much attention to him much earlier in my blogging career. After all, I’m a cancer surgeon, and here’s been this guy treating patients with advanced brain cancers with peptides that, according to Burzynski, do so much better against what are now incurable tumors than standard of care while charging huge sums of money to patients on “clinical trials.” It might be a cliche to quote the Dead this way, but what a long, strange trip it’s been. Because there was been a major development in this saga whose context you need to know to understand, I’m going to do a brief recap. Long time regulars, feel free to skip the next couple of paragraphs, as they just try to bring people up to date and include a lot of links for background, or, if you haven’t already, read this summary of Burzynski’s history published earlier this year in Skeptical Inquirer. Newbies, listen up. Read the next two paragraphs. You need to know this to understand why I’m so pissed.
When last we left Stanislaw Burzynski, for the first time in 37 years, he had published what was purported to be the complete results of one of his phase I/II clinical trials. The results were—shall we say?—underwhelming. Before that he had published 42.5% of one of his phase I/II trials, with even more unconvincing results. Meanwhile, since he received that warning letter from the FDA late last year, he’s been trying to enlist patients, both cute children and the semi-famous, to persuade legislators to pressure the FDA to let his clinical trials open again after they had been put on a partial clinical hold in the wake of the death of a child from hypernatremia (too much sodium in the blood), as reported by Liz Szabo in USA TODAY, all the while charging patients large sums of money, while bragging that he didn’t charge for the actual ANPs. For those unfamiliar with the story, a partial clinical hold means that Stanislaw Burzynski can’t enroll any new patients on clinical trial but can continue to treat patients already enrolled.
Three months ago—has it been that long already?—I noted with dismay that, under the onslaught of sympathetic cancer patients who understandably but incorrectly believe that Burzynski is their last chance to live, the FDA had started to show signs of caving on the issue of the partial clinical hold. Ultimately, the FDA did cave, although in the most weaselly way imaginable, stating that Stanislaw Burzynski could again enroll patients under compassionate use exemptions (also known as single patient INDs), even though the FDA warning letter had found gross deficiencies in the Burzynski Research Institute Institutional Review Board (BRI-IRB), which is run by an old crony of Burzynski’s who just so happens to be chair of the board of directors of the BRI and was found to be negligent in protecting patients by playing fast and loose with the regulations for enrolling patients on single patient INDs. The condition was that Burzynski himself or anyone working for him couldn’t be the physician treating the patients, leaving the patients to find a doctor willing to oversee the administration of ANPs.
And so it was for three months, with desperate patients with terminal brain tumors scrambling to find some doctor willing to do the paperwork to get the FDA to allow him to administer ANPs and also willing to work with such a disreputable character. McKenzie Lowe’s family, for instance, managed to find a retired family practitioner named Terry Bennett to agree to this. (More on this later.) Then, yesterday, this bombshell landed, courtesy of Liz Szabo again, in a story entitled FDA gives controversial doc green light to restart work:
The Food and Drug Administration has given a controversial Houston doctor the green light to resume administering experimental cancer treatments.
The FDA has lifted restrictions on a clinical trial run by Stanislaw Burzynski, who was the subject of a USA TODAY investigation last year. Burzynski, 70, has wrangled with state and federal medical authorities for nearly 40 years over his claims that he has discovered natural substances that can fight certain cancers.
You might think that my reaction upon reading this would be “WTF?” It wasn’t. However, that was only because I had had that reaction two days ago, when I read a press release from the BRI, Burzynski Research Institute, Inc. Announces Lifting Of The FDA Partial Clinical Hold – Phase 3 Clinical Study Agreed Upon:
The Burzynski Research Institute, Inc. (BRI) announced today that U.S. Food and Drug Administration (FDA) has notified the company that its partial clinical hold on its IND for Antineoplastons A10/AS2-1 Injections has been lifted. The FDA has determined that under its IND the Company may initiate its planned Phase 3 study in newly diagnosed diffuse, intrinsic, brainstem glioma. The Company is continuing discussions with the Agency in an effort to finalize additional details of the phase 3 study protocol for the potential clinical trial.
The FDA’s decision to lift the clinical hold marks an important step in the development of Antineoplastons for the treatment of various forms of brain tumors in the US. At the same time, the Company is evaluating possible next steps for the Antineoplastons clinical program given the current progress and anticipated resource requirements of the ongoing program.
That was when I had my “WTF?” moment. However, noting the obviously intentionally vague language of the press release, I decided to wait until I could learn more and obtain confirmation rather than to blog the press release. For one thing, Burzynski could just be spinning furiously, and there could be a lot less to this press release than meets the eye. It wouldn’t be the first time. Also, perhaps, even a Plexiglass box of blinky lights can experience a bit of denial. I just couldn’t believe that the FDA would so horrifically fail patients with brain cancer yet again the way it now has. I could sort of see why the FDA issued its previous ruling that allowed other doctors to enroll patients in single patient INDs of ANPs. At the time, the FDA was under a lot of pressure from legislators being contacted by constituents about families in their state or district with brain cancer who wanted to be treated by Burzynski. Its cynical solution must have seemed downright Solmonic at the time to the administrators who thought of it. But this? There’s nothing in the press release that says that the conditions that led to the partial clinical hold were resolved. Yesterday, however, there was this in Szabo’s story:
In a statement issued Wednesday), the FDA confirmed that it has lifted its restrictions on Burzynski because he answered all of their questions. In particular, Burzynski addressed “common and serious (and in some cases fatal) adverse drug reactions, as well as accurate information on how often tumors shrink after treatment with antineoplastons.”
Notice something missing? I did. The FDA said nothing about the BRI-IRB, which was soundly chastised for approving single patient INDs without full meetings of the committee. It also said nothing about the massive conflicts of interest that exist in the IRB and how it can’t possibly be independent. Sure, if Burzynski talked the talk adequately, I might see how the FDA might be either snowed or too tired to fight any more. I could see—but not approve—how they might be tempted to let him open his bogus clinical trials again—but only if Burzynski were forced to use a truly independent IRB, not his crony-packed IRB that basically rubber stamps whatever it is he wants to do with no questions and no evident effort to protect the welfare and rights of clinical trial subjects. Any IRB worth its salt will refuse to approve a clinical trial now and then and/or issue warnings to principal investigators for inadequate documentation, too many adverse events, etc. Has the BRI-IRB ever done this? Not as far as anyone I know can tell. Of course, it’s not really up to the FDA to oversee the function of IRBs. Rather, it’s more a function of the Office of Human Research Protections (OHRP). Long have I wondered: Where the heck as the OHRP been all these years?
It’s not as though Burzynski isn’t up to his old tricks again, either. Even with another physician overseeing the treatment of McKenzie Lowe, he’s managing to find ways to charge patients huge sums of money, even as he isn’t charging them for the ANPs. Indeed, the other day, Dr. Bennett, the physician who is overseeing the treatment of McKenzie Lowe whom I mentioned near the beginning of this article, was featured in an article in a local newspaper Dr. feels misled in cancer treatment costs. The money quotes are here:
But there was something Bennett didn’t know.
Bennett’s decision was based, in part, on a newspaper article that said Burzynski had agreed to donate the medicine required for McKenzie’s treatment. But what Bennett didn’t know is that Burzynki planned to charge the family for the clinical costs associated with the therapy.
LaFountain said the first month’s bill is expected to be $28,000. Every month after that is expected to cost $16,000. The treatment usually lasts eight to 12 months.
And health insurance won’t cover a dime of it.
Bennett says a representative of the Burzynski Clinic called him on that date seeking payment for the first month of McKenzie’s therapy. Prior to that, Bennett, who is donating his services, thought Burzynski was doing the same.
Instead, said Bennett, “I’m supposed to be the bag man for all of this. They want me to collect the 30 grand for the family and send it to Burzynski.”
Elsewhere, Bennett said, “It meets all the criteria for a bait and switch operation.” Yes, even Dr. Bennett found out the hard way how the Burzynski Clinic operates. None of this is anything new. Burzynski has been trying to dodge this tactic for years by saying that he doesn’t charge patients for his actual drug, the ANPs, giving the impression that he’s not charging them much of anything. However, the reality is that costs can rapidly add up to hundreds of thousands of dollars, which is why fundraisers by families of Burzynski patients have been a feature surrounding the Burzynski Clinic operation for decades, as I’ve documented time and time and time again.
This is a doctor who wants to help and is willing to take risks, even if inappropriately in this case, and he feels used by Burzynski. Indeed, his comparing himself to a “bag man” is a particularly apt metaphor, because that’s what he is in this: A bag man. It’s his job to collect the cash from the family of a dying child and ship it to his master in this case. Ironically, this news story appeared on the very same day as Burzynski’s press release, and, of course, Szabo’s story appeared yesterday. Did the FDA know Burzynski was doing this? It strains credulity to think that the FDA didn’t know about this abuse of a desperately ill child’s family, given that information regarding how it will be paid for is part of a single patient IND application, indeed part of all clinical trial applications. Indeed, that Burzynski gets away with this is yet more evidence that his IRB is nothing more than a rubber stamp, because any independent IRB would ask some very hard questions about such an arrangement. Very hard questions indeed. It’s painfully obvious that the BRI-IRB has never asked hard questions any IRB should be asking about any clinical trial Burzynski has proposed or about how his clinical trials are being carried out.
It’s even worse than that, though. Check out what I found on a website devoted to penny stocks, Burzynski Research Institute (BZYR) Reignites On FDA Approaval:
Focusing since 1967 on the isolation of various biochemicals produced by the human body as part of the body’s possible defense against cancer, the penny stock of Burzynski Research Institute, Inc. (BZYR) has exploded on the scene thanks to the efforts of CEO and President Stanislaw R. Burzynski, M.D., Ph.D. After notification that the U.S. Food and Drug Administration lifted its partial clinical hold on its IND for Antineoplastons A10/AS2-1 Injections, shares of BZYR stock begun to trade and are putting on a good show thus far. Although only around 25 million shares issued and outstanding do not belong to the founder who is determined to treat of various forms of brain tumors, the large jump upwards has made this little biotech burz-worthy.
You know, with all the typos and English that sounds as though it were written by someone who isn’t a native English speaker, this made me suspicious that Burzynski or someone from Burzynski’s clinic wrote it. Either that, or the web page is written by non-English speakers, which seems likely given that I found the same sorts of weird-sounding sentence constructions in other articles and I know Burzynski’s people can produce serviceable English prose when they need to. Be that as it may, I have little doubt that the Burzynski clinic is trying to take advantage of the FDA decision to bolster its flagging finances, which have been reportedly hurting since the partial clinical hold was placed. Whether this article on a website hawking penny stocks has anything to do with it, I don’t know, but its appearance right around this time sure doesn’t seem coincidental to me.
So what happened? Why did the FDA cave so ignominiously? How could it ignore 37 years of Burzynski’s therapeutic misadventures and abuse of science and the clinical trial process? I have a few ideas, but none of them are satisfying, and all of them are speculation, ranging from educated to, well, just speculation. Back in the 1990s, it was powerful legislators like Joe Barton leaning on the FDA to let Burzynski be Burzynski. Today, there are no visible and obvious champions in Congress for Burzynski. Even so, that doesn’t necessarily mean that such congressional patrons don’t exist, given the campaign waged by patient families and the Burzynski clinic to get people to write their Congressmen and Senators. Another likely possibility is that the FDA is just tired. If it shuts Burzynski down, it will be portrayed for years as the bad guy denying patients a chance at life, and there will be an enormous court battle. If it decides to fight, the FDA could end up with years of litigation, and, given the FDA’s unfortunately limited budget, it has to pick its battles. Does it help the the FDA mission overall if it drains so many resources fighting what it likely views as small fry like Burzynski that it finds late in the fiscal year that it can’t afford to go after a large drug company over lack of resources? I don’t know, but given how long Burzynski’s been at it, the FDA’s decision is still an extreme dereliction of its duty to the public.
Whatever the reason that the FDA caved, we’ll probably never know. We can make FOIA requests, but the FDA is notoriously tight with the information it permits to be releases because it’s forbidden from releasing information that might endanger trade secrets of the companies it regulates and it appears to take a fairly expansive view of what constitutes such information. At least, we’ll probably never know unless we can get a powerful Senator or Congressman (or two) interested and as outraged as we skeptics are. A Congressional investigation, as unlikely as that sounds, is probably the only thing that will get to the bottom of the FDA’s utter failure. It’s clear that in this case the FDA is no longer able or willing to protect the safety, finances, or rights of patients with advanced brain cancers.
ADDENDUM: My partner in this endeavor, the man who handles the skeptical activism while I try to handle and explain the science, Bob Blaskiewicz, asked me to post a message for him. So here it is:
Tonight, Thursday, June 26, I will be giving a presentation about Burzynski to the Skeptical Society of St. Louis. I would like very much to have a representative of Sen. McCaskill attend, as she did such an able job dismantling Dr. Oz last week. It’s clear that this nightmare will not end until the FDA’s bizarre relationship with the clinic is investigated by legislators. Please contact her St. Louis office and ask them to go out of their way to send a representative to the talk, which will be at 7PM at Pat’s on Oakland (in Dogtown, if anyone asks). Things are coming to a head and we need skeptics to ACT now more than ever to stop a medical ethics scandal that involves 8 times as many subjects as the Tuskegee Experiment. Thanks!
Sen. McCaskill’s office:
49 replies on “The FDA really caves: Stanislaw Burzynski can do clinical trials again”
BZYR has looked like a low-rent pump-and-dump darling for some time. Then again, there’s the issue of paying marketers in (expensed) ten-cent stock warrants.
I suppose an ominous irony lurking in the Lowe case would be if, after all the bleating about the mean FDA preventing access to antineoplastinoids, it would up being Count Scamula cutting them off for inability to pay now that the regular spigot has been fixed.
Does anyone have the text of the FDA statement?
I am starting to believe everything will shut down only when Burzinsky himself will die. If we are lucky.
The stock is publicly traded? Anyone think of filing a complaint with the FTC?
What would be the basis of complaint? Would need a clear legal violation that falls under the FTC’s purview.
Do you know what IRB approved Dr. Bennett’s treatment of Lowe? If he’s the PI in charge of the IND, he’d have to get IRB approval from somewhere. Was it BRI-IRB?
Excellent question. I don’t know which IRB approved Dr. Bennett’s single patient IND to treat McKenzie Lowe.
It would be interesting to find out, because they should have reviewed the bit of the consent form that discussed payment and expenses.
The stock is publicly traded, but on the “Other OTC” market. Rules for such stocks are notoriously pretty lax. I’ll look them up.
Here’s the NASDAQ Flash Quote page http://www.nasdaq.com/aspx/flashquotes.aspx?symbol=BZYR&selected=BZYR As you can see, it’s not exactly taking off in the wat the hypsters are claiming. Quite the reverse. Also, note that there are no institutional inverstors. Only private individuals who have there fore been royally conned.
$$$ speak louder than letters.
He gave $1000 to Joe Barton last September, plus what looks like about $4000 or so to the Republican National Committee in the current cycle so far:
I’m running late. But looking at the lobbying activities and expenditures of the ANH (and/or any other likely parties) might also be informative.
I suspect the author of that press release is an American with poor grasp of written English. Start with the dangling participle that implies the stock (not the company, which is what the author presumably intended) has been doing biomedical research since 1967 (at which point Dr. B was still in Poland)–that suggest someone who is trying and failing to write in a flowery style. But what seals the deal for me is the hideous pun “burz-worthy” at the end of the release.
But I agree with Todd W. that there isn’t a basis for a complaint here. The only people who would have standing would be suckers^H^H^H^H^H^H^Hinvestors who bought BZYR, and US law is designed to make such suits difficult if not impossible to win.
Try this: a sting operation.
Someone step up to the plate saying they’re impressed with Burz (we can use that nickname for him too) and they want to invest 10,000 USD. In order for any such investment to proceed, the investor asks for a prospectus or legal representations by the company.
Any such prospectus or material should have a section for disclosure of investment risk.
Send the document to a securities/investment fraud attorney.
Proceed per attorney’s recommendations. It might take an actual loss of money to get grounds for a case, in which case 1,000 USD wouldn’t be an excessive amount to flush down the loo in pursuit of justice.
And/or claim that the 1,000 USD is the first installment of a total of ten such installments. ‘I really believe in you but I’m not wealthy so I have to do this in small amounts of a thousand dollars each.’
After the first 1,000, start asking questions before ‘investing’ the next 1,000. You see where this goes, right? Each time you ask questions is another opportunity for Burz and his wretched minions to make more fraudulent claims.
Do all of this by email so there’s a written record.
Sooner or later he will trip up and make a fraudulent claim, probably sooner if he thinks the ‘investor’ is poor and therefore not knowledgeable about detecting quacks.
As soon as you have the necessary evidence, *boom!* hit him with the civil suit or possibly a criminal investigation.
BTW, I ran across a nice neologism for use alongside ‘pseudoscience,’ ‘quackery,’ and the like: ‘syence,’ describing the horse stuff peddled by the press in the interests of ‘balance.’
As if he’d ever try to finish a phase III ANP trial. This is beyond pointless.
I meant the SEC.
If the basis of the business is fraudulent, is there not a basis for action? At the very least, he could be forced to burn much time and money defending himself.
I’m dead serious. Call McCaskill’s St. Louis office, people.
@Michael – knowing what I know of the SEC, he’s a very small fish in a very big pond – I doubt that the Enforcement Division has either the time or resources to do anything…especially with the Congressional scrutiny that has the focused on large-scale white collar crimes.
@Michael: The SEC might be interested in any pump-and-dump activity associated with BZYR. But that’s not the same thing as going after the company directly. To do the latter, they would have to be able to prove something along the lines of cooking the books. It’s the FDA that has the nominal authority to go after Burzynski on the basis of what his company is doing, and the FDA appears not to be doing so.
Even assuming arguendo that BZYR is being pumped and dumped, that’s not necessarily Burzynski. Pump-and-dump scammers have been known to target innocent (for purposes of this statute) companies for their schemes. As Orac mentions in the OP, the press release on BZYR is likely to have been written by a third party–even though English is his second language, Dr. Burzynski seems to have a better command of it than whoever wrote that press release, and he can afford to (and usually does) hire competent wordsmiths for writing he doesn’t want to do himself.
I’d guess the event’s over. It went from 4 cents on the 23rd, to 16 cents on the 24th, to 8 cents yesterday.
[…] The FDA really caves: Stanislaw Burzynski can do clinical trials again (scienceblogs.com) […]
BZYR: short early, short as often as possible.
Thanks FDA, you made science cry.
Good point Space Trout! FDA made ME cry too. I lost a friend to cancer years ago – she tried going to Burzynski for stage 4 cancer of unknown primary and of course ended up on chemo since the antineoplaston treatment didn’t help. At the time there wasn’t as much analysis of Burzynski’s methods online as there is now, and his website with its “scientific” references made the treatment sound weakly plausible; even my friend’s oncologist didn’t object! Orac and others do everyone a great service by analyzing Burzynski’s publications and pointing out the huge flaws in his methods as well as sorting fact from hype. One thing I really don’t understand is how the FDA can allow even one clinical trial to resume after finding (last year) that Burzynski destroyed some of his patient records? Arrrrrggghh.
B. increased his monthly “case management fee” from $7,800 to $16,000. Gosh why would he do that?
I obtained the BRI-IRB roster from OHRP – it’s the same as the board of the directors listed in the IRS Form 990 for 2010.
In December of 2013 BRI-IRB member Dale Haufrect MD got a Cease and Desist notice from the TX medical board for practicing telemedicine without a license and for using the “MD” without clarifying he wasn’t licensed to practice medicine – since 2002 no less.
Orders are online thru his TX physician profile. Search here: https://public.tmb.state.tx.us/HCP_Search/SearchInput.aspx
SEC: BRI is interesting … According to SEC annual reports, year in and year out Dr B. gives $5 million from his medical practice to BRI to pay for ANP trials. This is odd for several reasons.
The trials are already paid for by subjects, as we know.
Over the past couple of years, BRI has had fewer and fewer employees yet every year BRI looses the same $5 million “conducting the trials” – how can this be? Perhaps Dr B receives some tax advantage, which may be perfectly legal, from this consistent annual $5 million loss?
In 2002 FDA issued Dr B an untitled letter, a lesser species of warning letter: http://www.circare.org/info/bri/fda_burzynski_20020429.pdf
Few people seem to be aware of this letter. Establishment Inspection Report: http://www.circare.org/info/bri/burzynski_fda-eir_20010810.pdf
Dr B response to FDA: http://www.circare.org/info/bri/burzynski_fda_20010923.pdf
Synopsis: same issues as the 2013 warning letter. You have to wonder if FDA bothered to read the 2002 documents.
Actually, I’ve pointed that out and written about the problems with the BRI-IRB and how the FDA has issued multiple warning letters dating back at least to 2001, citing that very letter from 2001:
All of this is why I knew that sooner or later the FDA would almost certainly lift the partial clinical hold on Burzynski’s clinical trials.It seems that Burzynski would have to go on a chainsaw murder rampage against the patients in his waiting room before the FDA would think about shutting down his clinical trials.
But if they pay the medical practice, which transfers the $$ to BRI, which spends it on clinical trials — if the practice acts as a pass-through for BRI, basically — neither will be burdened by much corporate income tax.
Wait. Maybe that wouldn’t be necessary. I’ve confused myself.
“a chainsaw murder rampage against the patients in his waiting room”
That would be an alternative and innovative form of surgery, duly approved be his personal IRB, and available at the low, low price of $50K.
BRI reports income? I’m not going back into those SEC filings anytime soon.
^^The tax advantage is to the practice.
BRI reports income?
I think the point of a pass-through is to avoid having corporate income to report. If I’m reading Ann’s post right, there may be other, less complicated ways to achieve the same result. But this is outside my area of expertise.
IIRC, checks are made payable to Dr. Burzynski himself, rather than to BRI. Indeed, the Burzynski Clinic web site has a page for donating to support clinical trials and research, where it directs people to make checks payable to “S.R.Burzynski, M.D., Ph.D.”
Good grief I spaced out. If FDA’s condition is indeed that neither Dr. B nor any of his folks can administer ANPs, I *think* this means Dr Bennett is the clinical investigator per 21 CFR 312 (Investigational New Drugs).
Does he have any idea what this means? Just thinking of the tons of paperwork he’ll need to generate and the records he needs to keep makes me dizzy.
It also means that the only people who can take care of Miss Lowe wrt to administration of ANP, aside from him, are sub-investigators (if any) listed on Form FDA 1572. It’s a given that B couldn’t be a sub-investigator. It’s mind-boggling & I hope Dr Bennett consults the best expert in FDA regulated research money can buy before he starts. He also needs to speak to his professional liability insurance carrier because med mal policies as a rule exclude clinical trials.
Also, since Dr B is not the clinical investigator and cannot provide “care” (properly called experimental intervention), what the heck is going on with the $16 k monthly “case management fee”??? ANPs are free and as clinical investigator Dr Bennett will do what Dr B did so far as “care.”
I bet Dr Bennett could find a cheaper price for his patient on a month’s worth of IV fluids, catheters, IV tubing & connectors, and bandages etc. – no reason why the family should have to buy medical supplies from Dr B’s Southern Family Pharmacy, right? And I bet he can find a rental IV pump rather than the family being forced to buy it from BRI.
Well….I believe that properly speaking the point of a pass-through is to obscure the flow of funds. But I’m not an expert myself.
And you’re right that I was thinking it would be sort of like a write-off, effectively.
@Agrippina: It’s not clear whether the lifting of the clinical hold lets Burzynski administer ANPs again, but I think that it does. As for Dr. Bennett, here’s my guess. If he were to get supplies anywhere else besides the BRI, I bet Burzynski would find an excuse to cut off the ANP supply.
Is he an actual oncologist, or does he claim to be one, a bit like he claims to have a PhD (Saul Green at Quackwatch claims its (his PhD) questionable). Even if he is a medical oncologist he is still a fraud selling drugs that don’t work and taking people’s life savings to pay for it, in some cases people have been killed by his incompetence and/or his drugs. He should be struck off and imprisoned and his assets sold and any money made given back to the families. Also serious questions need to be asked of the FDA and possibly an independent inquiry started. Hell will freeze over before he publishes his ”trials”
@AdamG#20 That’s beyond low!
I’m relying on this quote from Liz Szabo’s March 23, 2014 story:
“The FDA acknowledged Friday that it has agreed to allow them to use the experimental drug, but only if they can find a qualified, independent physician to administer the drug. Beyond infusing the drug and overseeing their care, the doctor would have to formally apply for expanded access to an “investigational new drug,” as well as get approval from an institutional review board, an independent panel that reviews safety and ethical issues involved in clinical trials. ”
Liz knows FDA-speak & I’m confident in the precision/accuracy of her prose. I believe the above does indeed mean neither Dr B nor any of his employees can administer ANPs in single patient INDs/compassionate access, save to discharge the obligations of sponsor. BTW the exclusion of Dr B as clinical investigator is consistent with BRI press releases on the perpetually-going-to-be-about-to-start-for 5 years phase 3 trial of ANP via FDA Special Protocol Assessment agreement – according to BRI part of the agreement was the trial had to conducted by an independent CRO.
If Dr Bennett intends to use BRI-IRB, he should get confirmation in writing from FDA that the previously imposed restriction on BRI-IRB approval of single patient INDs via compassionate access has been rescinded. (see warning letter to BRI-IRB)
My other concern is that with all due respect, Dr Bennett, not being an oncologist, doesn’t seem to be a well qualified expert (per above) nor does he appear to meet the statutory requirement that sponsors select clinical investigators who are experts in evaluation of the investigational new drug, as demonstrated by education, qualifications, experience, etc.
But HOLY CRAP! FDA requires a physician filing the single patient IND to act as sponsor as well as clinical investigator – see no. 7:
Something’s definitely changed, though, or else Burzynski wouldn’t have issued that press release. Three months ago, this was the situation:
This resulted in a mad scramble by Burzynski patients to pester oncologists and doctors to agree to line up to do single patient INDs which started to bear fruit a couple of months later, when Dr. Bennett agreed to treat Lowe:
And another doctor whose identity I do not know agreed to treat Liza Cozad-Lauser.
So what happened last week that led to the press release on Monday? So what’s changed between March and now? My guess? Unfortunately, it’s that the FDA really did reverse the partial clinical hold, as announced in the BRI press release, and Burzynski is back in business again. If that weren’t the case, then there wouldn’t be any talk of resurrecting Burzynski’s moribund phase III trial that was closed before it really even opened, and I highly doubt that Burzynski would have issued a press release.
Looks like April 11.
I called Sen McCaskill’s office–I hope others will quit going on about stocks and do the same.
BZYR on Jun 30 0.4299 Up 0.2854(197.51%)
That’s going to be tough to unload. The fresh meat is here.
The Short Report.
Just ran across this…
More woo-meistery in Texas to keep Stan, Mike, Andy and Jake company…
it seems that Grandmeister Null has established 2 non-profits in Mineola , TX:
a Veteran’s (sic) Village and a Nutrition Institute of America -as well as Health and Nutrition in Texas, Inc and Gary Null Holdings LLC. He is listed as Director of these esteemed entities sharing his duties with his woo-nurse and 2 other women. Papers were filed about year ago.
Abstracts CT-004, HG-017, and MB-039 here. Same old shit. In order (copy and paste, not proofed aginst PDF):
I sent a comment into moderation, but “possibly treatment related” “reversible toxicity” is a good one from abstract MB-039.
Oh wow, as GCP-CQA auditor, I would so love to get my hands on all of the regulatory files for this situation. How can a GP be qualified to be a PI on an oncology study? And the list just goes on ….
It seems self-evident to me that what happened is that they told him that if he didn’t publish the trials he’s already done and move on to phase 3, they were calling a halt to the whole charade. To put up or shut up, basically.
If so, it’s not such awful news, really. It would more or less mean that he’s in the overtime round, but (one way or another) the game is drawing to a close..
[…] you remember, last time I wrote about Burzynski, the Food and Drug Administration (FDA) had caved, and by “caved” I mean that it had lifted the […]