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FDA seeks tougher labeling for Byetta after deaths
They warned you once and they'll warn you again. FDA is upping the label ante on Byetta, the diabetes drug that Eli Lilly and Amylin Pharmaceuticals developed and market, following reports of deaths in patients taking the drug. Greater than 700,000 patients have used the medication since 2005, bringing the companies nearly $700 million in sales.
Patients taking the twice-daily injectable drug Byetta are at increased risk of acute pancreatitis, a dangerous form of pancreatitis that comes on suddenly and can be rapidly fatal, even with treatment. The FDA is warning patients on Byetta to stop taking the medication immediately if they develop symptoms of acute pancreatitis, including abdominal pain, nausea, vomiting, diarrhea, fever and chills.
The two drug companies say the reports of complicated or fatal pancreatitis are "very rare," and that diabetes patients already have an increased risk of pancreatitis.
The medication already had warnings following about 30 reports of nonfatal pancreas concerns in Byetta patients, but now the FDA has received at least six new reports of patients taking Byetta coming down with an aggressive type of pancreatitis. Of these, two have died.
For their parts, Lilly and Amylin are in the process of developing a once-a-week version of the medication that had piqued some investor interest despite recent lackluster sales, but this news has some analysts raising a red flag about investing, saying that it will likely influence how the FDA will view the new version. Not surprisingly, shares in both companies saw a dip in price on Monday.
--see the release
--read the story in the New York Times
--see more at ABC News
--find the Pharmalot blog post
Related Articles:
Does Lilly's Byetta extend life?
Lilly diabetes med linked to pancreatitis
Byetta - Top 10 Drug Warnings and Recalls
FDA Updates Information for Healthcare Professionals for Byetta
Novo drug bests Byetta in ADA study
Novo: no pancreatitis risk linked to Liraglutide
Comments
If I eat a new type of food and I die, along with others, the food is no longer available for this reason.
With drugs, people die, and a warning is issued.
Does our government really not want to prevent unneeded deaths? No one is doing anything about such events.
Our elected government has taken it upon themselves to establish and protect the agencies that are in bed with big pharma and biotech. Recent attempts by the FDA to win back some of the authority that it lost over the natural products and food areas (DSHEA Act of 1994), such as the requirement to report adverse events, is hugely disproportionate to events like the Byetta second warning. Yes, people continue to die and as far as the FDA is concerned, as long as Big Pharma has enough cash to pay fines, they;ll let them go on for as long as needed to suck out more sales and then force them into taking it off the shelves if it kills too many (what number is that, I don't know, but any number should be unacceptable). How these drugs get approved in the first place, one must question because of all of the conflict of interest that exists between those who review the submitted drugs and their likely association with the applying drug companies. Are they on the payrolls? Sometimes and if not, certainly the FDA is directly paid by the drug companies with fees to assess NDA, clinical studies and the like. Has the population of the United States objected? Only a little, but yet the FDA can apply a $25 million fine against products companies selling nutraceuticals like Airborne (for false advertising, I mean really. The FDA makes it's own rules, convicts those it pursues in it's own court and there is no prevailing protection for these companies targeted by the FDA), Ephedra products (the FDA could never link that any deaths actually came from ephedra ingestion) and are now targeting other naturals. Should the buyer that takes 10 times more ephedra than recommended be held responshible for his own stupid actions? Do prescriptions fall under the same scrutiny? Yes and no and the tragedy will continue as long as we continue to elect officials who are in the ocket of big pharma. Soon, we may all be told what and when to eat what foods, produced by companies in the pocket of Congress and the Executive. Just take a look at Dick Chaney and his oil buddies? Didn't think it was possible? Well it is and it's still going on.
Lorne Caplan
Lorne Caplan - Guilty of Wire Fraud
N E W Y O R K S T O C K E X C H A N G E, I N C.
EXCHANGE HEARING PANEL DECISION 02-211 November 7, 2002
LORNE JOEL CAPLAN
FORMER REGISTERED REPRESENTATIVE
* * *
Violated Exchange Rule 477 by failing to comply with requests for
information and for testimony – Censure and bar until he complies to
become permanent if he does not comply in six months.
Appearances:
For the Division of Enforcement For the Respondent
Simon Swidler, Esq. Marvin G. Pickholz, Esq.
Clarence E. Sanders, Jr., Esq.
* * *
An Exchange Hearing Panel conducted a hearing on charges brought by the Exchange’s Division
of Enforcement against Lorne Joel Caplan, a former registered representative with Brean
Murray & Co., Inc. (the “Firm”). Mr. Caplan was charged with having:
I. Violated Exchange Rule 477 in that he failed in one or more ways to comply with
written requests by the Exchange for information concerning one or more matters that
occurred prior to the termination of his status as a registered employee of a member
organization.
II. Violated Exchange Rule 477 in that he failed to comply with written requests by the
Exchange for testimony concerning one or more matters that occurred prior to the
termination of his status as a registered employee of a member organization.
Mr. Caplan submitted an Answer, through his attorney, which denied the essential allegations,
and denied the charges. Generally, Mr. Caplan claimed that he had attempted to cooperate with
the Exchange’s investigation in good faith, but that the Exchange had arbitrarily demanded
extensive information of him without informing him of the specifics of what was being
investigated.
Mr. Caplan appeared with his attorney at the hearing in this matter. On the basis of the
documentary evidence presented at the hearing, and arguments submitted, the Hearing Panel
found as follows:
2
Background and Jurisdiction
1. Lorne Joel Caplan (“Caplan”) was born on September 4, 1964. In or about
September 1993, Caplan entered the securities industry. In or about September 1994,
Caplan passed the Series 7 Examination qualifying him as a registered representative.
Except for the period of August 1995 to June 1996, Mr. Caplan was employed with
various securities firms from the period September 1993 to January 2002. He was
with the Firm from April 2001 to January 2002. Caplan has not been employed in the
securities industry since January 2002.
2. On or about February 25, 2002, the Firm reported to the New York Stock Exchange,
Inc. (“Exchange”) via a Form U-5, Uniform Termination Notice For Securities
Industry Registration (“Form U-5”) dated February 22, 2002, the January 25, 2002
termination of Caplan’s employment. The Form U-5 also reported that Caplan was
the subject of an ongoing internal review focusing on transactions involving an
escrow account.
3. By letter dated February 25, 2002, sent by Federal Express and first class mail to
Caplan at his last known address as reflected in Exchange records, the Exchange
notified Caplan of its investigation of the possibility that he may have
misappropriated funds belonging to a client of his member organization employer.
Failure to Cooperate
4. The Exchange’s letter dated February 25, 2002 requested that Caplan submit a
detailed written explanation of the matter(s) under investigation to the Exchange by
March 11, 2002. The letter advised Caplan that his failure to provide the requested
detailed written explanation could subject him to formal disciplinary action. On
February 27, 2002, Caplan’s attorney sent a letter to an attorney representing the
Firm, noting that Caplan was awaiting personal materials in possession of the Firm,
including materials predating his association with that Firm.
5. By letter dated March 25, 2002, Caplan, through his attorney, responded to the
Exchange’s letter of February 25, 2002, noting that the Firm had withheld materials
from Caplan, and requesting specifics as to the allegations against him.
6. By letter dated April 5, 2002, sent by fax and first class mail to Caplan’s attorney,
which his attorney received, the Exchange advised Caplan that his March 25, 2002
letter was not responsive to the Exchange’s February 25, 2002 request for a detailed
written statement regarding his possible misappropriation of funds belonging to a
client of his member organization. The Exchange requested that Caplan provide the
information by April 15, 2002 and advised him that his failure to do so could subject
him to formal disciplinary action.
7. By letter dated April 15, 2002, Caplan responded to the Exchange’s letter of April 5,
2002. While Caplan complained of inadequate notice of results of the Firm’s internal
3
investigation of him, he noted that he was aware of a particular financing transaction
that was under question; he stated that an issuer of a private placement and the Firm,
acting as placement agent, “had counsel who prepared various documents and guided
their clients in the private placement process,” but there had been a problem as to
delivery of funds to the issuer. As to a review of three transactions involving an
escrow account, as reported by the Firm, Caplan noted that he was “unable, at this
time, to respond.” There was no mention of any role Caplan played in these
transactions nor any denial that he had a role in these transactions.
8. By letter dated May 15, 2002, the Exchange advised Caplan that his March 25, 2002
and April 15, 2002 letters were not responsive to the Exchange’s February 25, 2002
and April 5, 2002 requests for a detailed written statement regarding his possible
misappropriation of funds belonging to a client of his member organization. The
Exchange’s letter of May 15, 2002 also requested that Caplan provide to the
Exchange specified financial records and additional written statements responding to
specific inquiries. Caplan was required to provide the financial records and
additional written statements by May 29, 2002 and was advised that his failure to do
so could subject him to formal disciplinary action.
9. The Exchange’s letter of May 15, 2002 also requested that Caplan appear at the
offices of the Exchange’s Division of Enforcement on June 18, 2002 and provide onthe-
record testimony in connection with the Exchange’s investigation. The Exchange
advised Caplan that his failure to appear and testify on the scheduled date could
subject him to formal disciplinary action.
10. By letter dated June 17, 2002, Caplan advised the Exchange that he would be unable
to appear on June 18, 2002.
11. To date, Caplan has failed to comply with the Exchange’s request for testimony. Nor
has Caplan furnished the information requested by the Exchange in its letter of May
15, 2002.
DISCUSSION
Initially informed that the Exchange was investigating the possibility that he may have engaged
in misappropriation of funds belonging to a client of his member organization employer, Mr.
Caplan eventually returned a vague response and a claim of inadequate specification of
allegations. The Exchange’s Division of Enforcement followed with a request for specific
information and for Mr. Caplan’s testimony. Mr. Caplan asserts that this request for documents
constituted “retaliatory action,” demanding “virtually every record and document relating to a
myriad of personal and business matters,” and the request for testimony could be a “snare,”
expecting answers when no specifics had been provided.
To the contrary, the Exchange’s request for documents specifically noted business relationships
under investigation. Moreover, Mr. Caplan was aware of the transactions under investigation,
having received his termination notice from the Firm. In his vague response to the Exchange, he
4
had expressed uncertainty as to topics under investigation, but he acknowledged he was aware of
a private placement at issue in the investigation and that he was aware of a review focusing on
the transactions involving an escrow account. But he provided no explanation as to his role in
these transactions, nor did he disclaim any such role.
Nor was Mr. Caplan surprised by the scope of the Exchange’s requests for documents. He
complains that the request went beyond his period of employment with the Firm. But the
Exchange’s request refers to a period in which he may have had outside business relationships
relevant to the investigation. Mr. Caplan had previously indicated his awareness that the scope
of the investigation could extend beyond his employment period; he had, in a letter to the Firm,
noted that the Firm had retained in its possession materials predating his association with the
Firm, which he wished to review.
As to the Exchange’s request for his testimony, Mr. Caplan indicated that he would be “unable to
attend,” on advice of counsel, “for the reasons previously stated.” It is somewhat disingenuous
now to claim, as he does, that this did not constitute a refusal to testify, but rather a desire for
informal discussion of the topics to be raised in such testimony.
Mr. Caplan notes that these charges issued without any effort to contact him to set another date
for his testimony. But, then, he has not since, even when charged with this failure to cooperate,
offered to appear and testify.
A person under the jurisdiction of the Exchange cannot dictate the terms of an Exchange
investigation into potential violations of duties as a securities professional. Those within the
Exchange’s jurisdiction who may have knowledge of possible wrongdoing within the scope of
their employment must provide such knowledge when asked to do so. Mr. Caplan has not
explicitly denied any such knowledge. He cannot seek to obscure his responses, while waiting to
see what information the Exchange has gathered elsewhere. Nor can he refuse to testify until he
has analyzed any information gathered against him.
Mr. Caplan argues that this investigation is a pretext to arrive at a predetermined result.
Certainly, the Exchange’s Division of Enforcement is charged with thoroughly investigating
alleged wrongdoing of those subject to its jurisdiction. But if one under investigation seeks to
assert his innocence, he should be willing to be responsive to the investigative inquiries.
In sum, Mr. Caplan is not entitled to monitor the course of the investigation in order to decide
when he is ready to give his own version of the events at issue. He has been more than
sufficiently informed of what is being investigated. His recalcitrance in promptly responding is
not acceptable.
In determining penalty, the Hearing Panel has taken into account Mr. Caplan’s representation
that he has been cooperating in a related government investigation and that, given additional time
to cooperate, he would waive review and accept the terms of this decision.
5
DECISION
The Hearing Panel, by unanimous vote, found Mr. Caplan guilty as charged.
PENALTY
In view of the above findings, the Hearing Panel, by unanimous vote, determined that
Mr. Caplan be censured and barred from membership, allied membership, approved person
status, and from employment or association in any capacity with any member or member
organization until he complies with the Exchange’s requests with which he has failed to comply.
The Hearing Panel, by unanimous vote, further determined that Mr. Caplan be permanently
barred from membership, allied membership, approved person status, and from employment or
association in any capacity with any member or member organization if he does not comply with
the Exchange’s requests, with which he has failed to comply, within six months from the date
this decision becomes final.
For the Hearing Panel
Milton M. Stein
Hearing Officer
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