NYT's MannKind Story Needlessly Quoted a Competitor Bashing Afresa

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Management at MannKind will doubtless be furious at a New York Times story over the weekend in which a vp for a rival company, Generex, was quoted casting doubt on MannKind’s product. The story, under the rubric “novelties,” summarized the case for MannKind’s inhaled insulin product, Afresa. It quoted an analyst and a doctor, and then Dr. Gerald Bernstein (pictured).

BNET readers first met Bernstein in September 2008 when we published a Q&A with him. In addition to being a former president of the American Diabetes Association, Bernstein is currently vp medical affairs at Generex, which has an oral-spray insulin product in development, called Oral-Lyn. Bernstein was quoted by the Times as agreeing that “the long-term use of inhalable insulin might carry risks for some patients”:

“It’s counterintuitive to use the fragile cells of the alveoli,” the tiny air sacs within the lungs, “to get insulin to the bloodstream,” he said. “The lungs were developed to transport gases, not proteins.”

The Times noted that Bernstein worked for a company producing an oral insulin product, but didn’t make clear that if both Oral-Lyn and Afresa are approved they could find themselves in direct competition. That’s a war Generex might win, because doctors have fewer concerns about the long-term safety of absorbing insulin through the cheek than through lung tissue. In addition, Bernstein has previously complained that the “cloud” hanging over inhaled insulin has reduced interest in potential acquirers or partners looking at Generex.

Put another way, asking a Generex exec to comment on MannKind’s product is a bit like asking Steve Jobs to assess the new Windows 7 operating system from Microsoft. Such a review is unlikely to be kind.

One last aspect to the mystery: Why the author, Anne Eisenberg, needed to quote Bernstein in the first place. She had other non-conflicted experts already quoted in the piece, and diabetes commenters are not difficult to find.

Tags: Insulin, NYT, MannKind, Generex, Jim Edwards

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

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1

BankLoans

10/12/09 | Report as spam

RE: NYT's MannKind Story Needlessly Quoted a Competitor Bashing Afresa

Obviously there are a lot of of people who are against MannKind for one reason another. The frustrating part is that it starts to feel as though there is a conspiracy against the company. I don't mind conflicting opinions, but when people misquote and provide inaccurate or misleading information it brings their motives into question.

(your last post on MannKind's failure to secure a partner is an example of my frustration.)
2

silentbobsilent

10/12/09 | Report as spam

RE: NYT's MannKind Story Needlessly Quoted a Competitor Bashing Afresa

Hi Jim,

The first doctor quoted in this article, Poretsky, also has links with Bernstein and Generex .

Consider the following article at NYTimes in 2006:
http://www.nytimes.com/2006/01/11/nyregion/nyregionspecial5/11diabetes.html?pagewanted=all

Poretsky has a high position at Beth Israel. Coincidentally, that is where Bernstein discovered Generex's buccal insulin spray when he was teaching there at the time. Furthermore, Bernstein is currently still an attending physician at Beth Israel. This demonstrates a long term collegial link between the two, and seeing how Bernstein is Director and VP of Generex, Poretsky is linked to Generex as well.

I believe it might be interesting if the following questions were answered :
- Is there a financial link between Beth Israel and Generex? For example was the Generex buccal insulin spray licensed or purchased from Beth Israel?
- Does Poretsky have a financial link to Generex? Does he hold shares or options?

------------------------------------------

Aside from their smear campaign against Mannkind, something else smells funny at Generex. Quoting myself here:

"Their buccal spray is not even in trials in the US or EU and I doubt they ever will. The bio-availability of buccal administration is a lot lower then inhaled insulin and would require 5 to 10 times as much insulin at every meal, most of which is broken down in the stomach acids. Oralyn is approved in some dubious countries, yet they have no customers for the product. Still Generex keeps promoting the spray just so investors keep buying more shares when they do yet another secondary offering. If you are willing to do some research I am sure you could expose their dubious ways of prying money from investors just to finance their own paychecks."

----------------------------------------

Anyway for the moment I am assuming that the NYTimes author simply did not think twice about Bernstein's link to Generex, and possibly did not know about the Poretsky's link to Generex. However I have emailed here about this issue a few days ago and did not yet receive a response.

----------------------------------------

Anyway thanks for taking Mannkind's side this time. You're probably thinking here's silentbob the guy who always complains about the bad press, and raves about good press. I point out mistakes in articles and I can imagine such criticism isn't easy to tolerate.

But to be honest about the only good press Mannkind gets is in the medical press. Mainstream press is mostly negative, and not all for the right reasons. Mannkind does not deserve all the negativism.
3

sxiao

10/12/09 | Report as spam

RE: NYT's MannKind Story Needlessly Quoted a Competitor Bashing Afresa

SilentBob,

MNKD gets good press and bad press. I'm guessing that this has something to do with the potential impact of this product and the divergent views of those in the medical and user communities. Certainly the jury is still out on the ultimate success or failure of this product.

In contrast, Oral-lyn and GNBT do not get much attention. The previous actions of big pharma, little pharma, institutional investors, analysts and users in countries where Oral-lyn is CURRENTLY available for sale would suggest that Oral-lyn has all but been eliminated as a possible WIDELY USED treatment option. This is why you don't see much discussion/debate about Oral-lyn. Because the market for Oral-lyn is small it is not surprising that GNBT focuses its regulatory approval efforts on countries where the regulatory burden is low (Ecuador, India, Iraq, Lebanon, Algeria). In the US they've seriously scaled back phase 3 studies. While all the smart money has bailed out of GNBT years ago, many small unsophisticated retail investors don't realize this and are clinging onto the hopes and dreams from years gone by.
4

beeniecopter@...

10/12/09 | Report as spam

RE: NYT's MannKind Story Needlessly Quoted a Competitor Bashing Afresa

Shorts full-court press against MNKD will fail.
5

rjs9787

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RE: NYT's MannKind Story Needlessly Quoted a Competitor Bashing Afresa

Quote from silientbobsilent: "Coincidentally, that is where Bernstein discovered Generex's buccal insulin spray when he was teaching there at the time."

Hi Bob. Dr Gerald Bersntein did not invent Oral-lyn. He was the President of the American Diabetes Association and not affiliated with Generex when they began developing buccal insulin with a Dr Modi in Canada. Oral-lyn was not developed at Beth Israel and Dr Poretsky is not affiliated with their company. Dr Bernstein had many opportunites when his tenure as ADA President ended and has long stated that inhaling a protein such as insulin may have negative pulmonary effects in the long run. He promotes the safety profile of Oral-lyn and has studied its effectiveness in a few Phase II, and now Phase III, trials. Also from bob:

"Their buccal spray is not even in trials in the US or EU and I doubt they ever will."

That isn't right either:

http://clinicaltrials.gov/ct2/show/study/NCT00668850?term=oral-lyn&rank=1&show_locs=Y#locn

Last month, Generex Oral-lyn received FDA approval for a treatment investigational new drug program, which allows drug makers to make unapproved drug available to patients with dangerous illnesses who don't have a satisfactory treatment. A new paradigm in safe, effective and non-invasice diabetic care is here.
6

Stunner21

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RE: NYT's MannKind Story Needlessly Quoted a Competitor Bashing Afresa

rjs9787:

"which allows drug makers to make unapproved drug available to patients with dangerous illnesses who don't have a satisfactory treatment"

...that's like saying if all diabetes drugs ceased to exist then they can finally use GNBT's Oral-lyn. Sorry to break it to you, but there are many insulin's that are way ahead of GNBT's that are "Satisfactory".
7

beeniecopter@...

10/13/09 | Report as spam

RE: NYT's MannKind Story Needlessly Quoted a Competitor Bashing Afresa

OraLyn, Oral cancer?

Possible.
8

silentbobsilent

10/13/09 | Report as spam

RE: NYT's MannKind Story Needlessly Quoted a Competitor Bashing Afresa

rjs9787:

---> I do not know much about Generex or the origins of Oralyn, but please read the following article on Beth Israel:

http://www.nytimes.com/2006/01/11/nyregion/nyregionspecial5/11diabetes.html?pagewanted=all

Quotes:
- "Dr. Leonid Poretsky, who became director of Beth Israel's endocrinology division"
- "Once the center had closed, Dr. Bernstein continued to teach at Beth Israel, but he began to devote more and more time to a side project. He was working on an inhaler that delivers insulin in the form of a mist. The product is being developed by Generex <...>"

---> Also consider the Generex website:

http://www.generex.com/management.php?id=mgmt

Quote: "Dr. Bernstein, M.D., ... ... He is an attending physician at Beth Israel Medical Center, ..."

---> And some new info, check the second one of only two Oralyn entries with the FDA :

http://clinicaltrials.gov/ct2/show/NCT00948493?term=oral-lyn&rank=2

At this time the only clinic registered in the locations for this Oralyn/Generex treatment IND is Beth Israel, whose endocrinology division is headed by Poretsky.

The link between Poretsky and Generex/Bernstein is hereby well established, and maybe a professional could find out a lot more.

-------------------------------------------------

I concede, you are right that there is one trial running for type 1 diabetes. About 5% to 10% of diabetics have type1. If I could correct my comment above, I would. Please accept my apologies and please accept this statement as a correction for the above.

My knowledge of Generex is clearly out of date. Would you mind satisfying my curiosity?
- Was the study design coordinated with the FDA? Didn't Generex just state this summer that they were starting up conversations with the FDA w.r.t. trials for marketing approval?
- Has Generex explained why the study has been recruiting for 18 months, even though the treatment period is only 6 months, and only a few hundred patients were targeted for study endpoints?
- Did Generex give any comment on the drop out ratio for these studies?
- Why are they comparing against the extremely slow regular human insulin? Why don't they use a rapid acting insulin analog? Is the FDA OK with this?

Thanks in advance.

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