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Firms Promise To Put You in Google’s Good Graces

February 28, 2007

All HGTV wanted to do was promote its TV show. But it kept running up against Cialis users.

To publicize its reality show Living with Ed about actor and environmentalist Ed Begley Jr., and his wife, HGTV was hoping to get some blog buzz going before the Jan. 1 premiere.

But in December, if you Googled the term “living with Ed,” you mostly got sites that dealt with living with E.D., as in “erectile dysfunction.”

HGTV relied on New York search marketing agency 360i to fix the problem. “What was interesting to me personally was the metrics,” said Mike Boyd, svp-marketing at HGTV, Knoxville, Tenn. “To go from page 5 in mid-December to 10 of the top 12 search results a month later was terrific. We pushed Cialis down to page 2.”

What HGTV tasked 360i to do is a new discipline that is a mix between search engine optimization and public relations. So far, it lacks a catchy name. Some call it “brand protection” while others dub it “reputation management.” Several firms, including 360i, USWeb and iCrossing claim they can improve a brand’s image on Google searches, whether it be to dispel confusion or to push critical mentions down further in searches.

Bryan Weiner, president of 360i, said most marketers aren’t aware of the need for the service. But he urges them to think of Google search results as shelf space. “Google is a brand vehicle.” Wiener added that the agency is able to increase such rankings by search-engine-optimizing Web sites related to the brand and by engaging bloggers, whose positive mentions of a brand can crowd out brand-bashing sites. Others recommend sub-domains (like “music.walmart.com”) to achieve the same goal.

Not everyone agrees such services can deliver what they advertise. “Getting an anti-Wal-Mart site off the top 200 listings is not something that anyone can do anything about,” said Gene Lewis, director of Web and technical development at Digital Pulp, a New York interactive firm. “Protecting your message on the Web just isn’t possible.”

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But iCrossing, a New York SEO firm, argues that the risk of doing nothing is too great to ignore for marketers in any category. While many are aware that autos and consumer electronics are highly searched items, iCrossing released a study in conjunction with Harris Interactive last December showing 39% of respondents performed an online search for packaged goods. Two-thirds of respondents said they would also buy that searched-for product later, either on- or offline.

ICrossing used that argument to get work with Coca-Cola, though an agency rep declined comment on what that work entails.

The agency also has engaged bloggers and consumers on behalf of Palm’s Treo Smartphone. Lewis said the latter is the right way to tweak search rankings. The wrong way, he said, is to create fake blogs (or “flogs”) to create the illusion of positive sentiment.

That was the approach Wal-Mart took with Edelman Public Relations last year. Edelman set up blogs like Wal-Marting Across America and blogs on Working Families for Wal-Mart, an “astroturf” advocacy group set up by the retailer. An Edelman rep declined comment on the issue. Sony was also caught setting up flogs for its PSP product.

Because the Web is a transparent medium, reputation management firms recommend resisting the urge to create such sites. John Tawadros, COO of iProspect, a Boston search engine optimization firm that works with a “fairly large consumer packaged goods firm” on its reputation management, says there’s a simple reason for that: “The moment you start to fabricate, you’re bound to get caught.”

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When it comes to sex, Americans are more watchers than doers

February 27, 2007

Americans are confused about sex. Many of the first colonists were Puritans, and a strong puritanical streak still runs through our culture.

Although our sitcoms and soap operas rely on sex to keep viewers watching, many of us consider this type of entertainment a guilty pleasure.

Despite our seeming obsession with sex on television, in movies and on the Web, Americans are actually more watchers than doers. We’re a voyeuristic society that seems content to observe others acting sexy.

According to some global sex surveys, Americans lag behind people in France, Greece, Croatia, Poland, Great Britain and even Kazakhstan in having sex.

Part of the problem might be that Americans work too hard. A survey for the National Sleep Foundation found that nearly one-fourth of the couples surveyed were often too tired to engage in sexual activity.

We are so busy with work, family responsibilities, e-mail, television and other distractions that we just don’t find enough time to relax and get in the mood. A commercial on television for the erectile-dysfunction drug Cialis asks, “If a relaxing moment turns into the right moment, will you be ready?” If there are no relaxing moments, however, Cialis won’t do much good.

Besides being overscheduled and stressed out, many people are unclear about the differences between an anti-impotence drug like Cialis or Levitra and an aphrodisiac. When the first medication against erectile dysfunction, Viagra, was introduced, it quickly became a household name. People talked about it with the kind of leer reserved for raw oysters.

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Those who expected Viagra to increase libido were soon disappointed. While this medication is considered effective for helping a man achieve an erection, that achievement is possible only in the presence of sexual desire. Medical science is still looking for ways to increase libido.

Too many medicines do the opposite — dampen desire. Many Prozac-like antidepressants interfere with arousal or function. Birth control pills, hormone replacement therapy and even some blood pressure medications can reduce interest in making love.

We have listed many common culprits in our Guide to Drugs That Affect Sexuality, and we have discussed ways to overcome low libido in our Guide to Treating Sexual Dysfunction. Anyone who would like copies, together with a one-hour CD radio interview with Dr. Irwin Goldstein, one of the country’s leading experts on human sexuality, may send $18 to: Graedons’ People’s Pharmacy, No. YP-561, P.O. Box 52027, Durham, NC 27717-2027.

There are a few compounds that might eventually turn out to be helpful for improving libido. Some years ago, Dutch researchers discovered that giving women a small dose of testosterone under the tongue increased their interest in an erotic video (Archives of General Psychiatry, February 2000).

A recent study found that sniffing a compound isolated from men’s sweat, androstadienone, could increase cortisol levels in women’s blood and make their hearts beat faster (Journal of Neuroscience, Feb. 7, 2007). It also improved their mood and boosted their sexual arousal.

Perhaps someday scientists will create a true aphrodisiac. Until then, Americans might need to learn how to relax and rediscover romance.

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Let us pause to hail genius now muted

February 21, 2007

Robert Adler reportedly never understood the appeal of the invention that came to define his career.

Not to dispute the holder of 180 U.S. patents, but any device allowing us to mute Geraldo without leaving the sofa is worthy of a Nobel Prize.

Adler, the father of the TV remote control, died Thursday at 93. That evening, my friend Steve and I were moving bedroom furniture in an effort to locate a descendant of Adler’s 1956 invention.

It probably bedeviled Adler to know that some people search harder to find a missing remote than they do a lost pet. The longtime Zenith employee rarely watched television, according to a Chicago Tribune obituary.

It stands to reason that you don’t become a distinguished engineer by devoting a two-hour daily block to Divorce Court and Judge Mathis.

Adler and Eugene Polley, the remote’s co-inventor, helped create a sedentary lifestyle that has been celebrated in beer commercials and reviled by some parent groups.

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As a card-carrying couch potato, I applaud the invention and raise the footrest on my recliner in Adler’s memory.

The remote control not only supplies convenience but also provides the common man something he rarely enjoys — power and instant gratification.

With the click of a button, we don’t have to suffer through another Cialis advertisement. We don’t have to walk across the room to let Chris Berman know that his shtick has grown stale.

I can spend a Saturday afternoon lonelier than Eleanor Rigby and still entertain myself by flipping among four basketball games on DirecTV. Such lazy days have no doubt led many a spouse to consider calling the producers of Divorce Court.

If Adler or the designer of the universal remote could have developed a no-break battery latch, the device would be perfect.

Then again, we’d never have a reason to praise the inventor of duct tape.

Dispatch Reporter Tom Reed has a thick callus on his right thumb.

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Web drug sales are bill’s target

February 20, 2007

A state senator hopes to crack down on Internet sales of “lifestyle drugs” by requiring a bona fide patient-physician relationship before medication can be prescribed.
“This bill is a health and safety bill that will protect the public and others from Internet prescribing of potentially dangerous drugs,” Sen. Pete Knudson, R-Brigham City, told members of a legislative committee Friday morning.
Specifically, Knudson is concerned about the use of the Internet in the abuse of erectile dysfunction medications, which have potential for dangerous side effects. The drugs are “popularly used by young people as an aphrodisiac,” not as a medical necessity, he said.
“These lifestyle drugs, when abused by young adults, are most commonly ordered on the Internet,” Knudson said.
SB146 is being strongly opposed by an Arizona-based company that fills online prescriptions for the erectile dysfunction drugs Viagra, Cialis and Levitra and the hair-loss medication Propecia.
After a lengthy process involving various stakeholders, the state Division of Occupational and Professional Licensing entered into a consent order with KwikMed in December 2003.
“The basic sense of the group was that the Internet was indeed going to be the wave of the future for health care and that we could either fight it, like most others have chosen to do, or we could see if there was something that could be done,” said Laura Poe, DOPL bureau manager.
No other companies have similar agreements with the state, though at least one organization has expressed interest.
The consent agreement allowed the company to issue online prescriptions after would-be patients successfully completed what the company calls “a meaningful online assessment.” Patients are approved or rejected based on a staff physician’s review of their answers.

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On Friday, KwikMed attorney Kevin Marino told lawmakers the sophisticated online assessment is virtually impossible to fake and the company’s policy of requiring an adult signature upon delivery ensures that no minors receive prescription medication.
Utah is the only state that has any type of formal agreement with an online pharmacy, giving KwikMed the right to make the claim on its Web site that it is the only company granted regulatory approval to offer prescriptions with an online diagnosis.
Poe said KwikMed has always been open with the agency, allowing the state to track prescriptions and responding quickly to any complaints the agency has received.
DOPL has taken a neutral position on SB146, saying the matter is a “policy decision.”
“We will follow whatever the Legislature tells us to do,” Poe said. “Again, we would say that we’re comfortable with the consent agreement that we’ve entered into. It was not entered into lightly, and it’s being evaluated on an ongoing basis.”
Under the terms of the consent decree, the remedy for a change in state statute affecting the agreement is the court system, meaning a possible lawsuit if SB146 is ultimately approved.
At least one lawmaker expressed concern, however, that the company may simply begin to sell its drugs illegally, as many other online pharmacies do.
“You can buy Viagra online through any number of tawdry Web sites, and it seems like these folks have actually taken the time to try to provide that service in an upfront, honest and responsible way,” said Sen. Scott McCoy, D-Salt Lake, who voted against SB146.
The Utah Medical Association supports the bill, said president Michelle McOmber, because it preserves an important relationship between doctors and patients. Many physicians, especially in rural areas, use the Internet to correspond with patients and give medical advice, but only after the two have established a relationship through in-person contact.
According to her understanding of SB146, that would not be prohibited by the legislation, McOmber said.
The bill passed the Senate Health and Human Services Committee with a vote of 3-2. It now goes to the full Senate for consideration.

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Basu: Hearts, flowers for Valentine’s? That’s so quaint

February 14, 2007

Mating rituals just aren’t what they were when Valentine’s Day got launched some 18 centuries ago. For one thing, there’s nothing quite like facing the gallows to get the romantic juices flowing. Several of the earliest Valentine’s Day legends, including one of a priest named Valentine, involve love notes written by people facing beheadings in the morning.

But what about 21st-century lovers who have no expectations at all for the next morning - or wouldn’t plan to greet it together in any case? I’m thinking Hallmark needs to update its Valentine’s messages.

The boilerplate, “To my wonderful husband on Valentine’s Day,” just doesn’t cut it for everyone in the era of rainbow parties, cybersex and connecting on the sly. What if you’re respectably married but doing it “on the down low” with someone of the same sex at a bar? Surely that person deserves a Valentine, too - something like, “To my wonderful side dish: Keep it on the QT.”

Or the couple that just hooks up from time to time - the friends “with benefits?” Shouldn’t they have a way to say they care that’s not quite so, umm, love-focused?

Instead of the pressure-inducing “Will you be my Valentine?,” which might cause commitment-phobes to flee, how about a more open-ended, “You rocked!” No demands, no expectations, no guilt.

The greeting-card industry needs to get with it, if not for the sake of being inclusive, then for the need to stay in business. By industry estimates, about a billion Valentine’s cards are sent out worldwide every year. It’s a safe bet not all of those partnerships are of the true-love kind.

You laugh? You’re out of touch. I was, too, until last week. I was in Florida at a journalism seminar that dealt, among other things, with sexual power dynamics. But it was outside the classroom that I picked up some new vocabulary. “Hate-sex,” for example.

Maybe you’re familiar with this concept. I asked the person who said it for a definition, and she obligingly wrote this Webster-style one:

“Hate-sex: 1. Rough sex motivated by angry feelings, presumably (by) both parties and presumably by choice.

2. A subset of ‘breakup sex.’

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3. Sometimes a choice between otherwise loving, consensual parties - pure role-playing.”

It turns out there are definitions for hate sex online, some of which are more disturbing.

I wasn’t familiar with “breakup sex” either, after spending 21 years married without interruption. I also didn’t know there was a thing called “makeup sex,” although that wouldn’t take much imagination to contemplate.

It might be a generational thing. The people who knew about hate sex are 12 or 14 years younger than me. My generation hears more about things like Cialis.

Baby boomers aren’t the only ones drawing blanks at relationship terminology. Ask a high school student about “dating” and you may be asked to define your terms. In her new book “Unhooked,” Washington Post writer Laura Sessions Stepp says young people are replacing dating with casual sex, and that it’s often young women who want it that way.

Did you know about being “gay for the stay?” That’s what some people opt to be only while in a same-sex environment, like prison or boarding school or college.

If you think hooking up today is easy, think about some of the challenges, like one outlined in a recent Glamour magazine advice column: The problem of breaking it to the guy you’ve just started seeing that you got breast implants. Maybe a thoughtful “Could have fooled me” Valentine would be the way to show that person it’s OK.

And don’t people having cybersex have feelings, too? What a considerate gesture it would be to tailor a Valentine specifically to them. The only problem would be where to send it when you don’t know your partner’s name.

I learned a lot last week. But of all the trends I heard about, maybe the most shocking involves a growing move toward celibacy by choice. Not to be confused with the federal government’s heavily funded abstinence-only campaign for the unmarried, this movement is among those who have been sexually active but just want a break.

Little wonder. All these mating rituals would be exhausting to keep up with.

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Doctor to see prison for sham scripts

February 13, 2007

EAST BRUNSWICK — Philip Mach, the local doctor who pleaded guilty in August to writing sham prescriptions, will be sentenced in Minnesota in the coming weeks, according to the office of the U.S. Attorney there.

Under the plea agreement, Mach faces a prison term of between 30 and 37 months if federal authorities determine he cooperated with their investigation.

Mach, 49, could otherwise be sentenced to a maximum of 15 years following his guilty pleas to two counts of conspiracy to distribute controlled substances and a single count of unlawful distribution of a controlled substance.

While Mach, an internal medicine and pulmonary disease specialist whose office is on Dunhams Corner Road, is still licensed to practice medicine, a forthcoming consent order from the New Jersey Board of Medical Examiners could change that. Mach’s license to prescribe controlled substances was suspended soon after his plea.

In exchange for Mach’s guilty pleas, and for his agreement to cooperate with investigators and to testify against co-conspirators, federal prosecutors dropped multiple counts of wire fraud, of unlawful distribution and of introducing misbranded drugs into interstate commerce.

Mach also agreed to forfeit the profits he made from the online pharmacy scheme, which totaled at least $200,000, according to authorities.

Neither he nor his attorney could be reached for comment.

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Mach was indicted in August 2005 by a federal grand jury in Minneapolis on charges of illegally issuing roughly 72,000 prescriptions through an online pharmacy business.

The indictment charged Mach and his primary co-conspirator, Christopher William Smith of Prior Lake, Minn., with conspiring to distribute controlled substances “other than for a legitimate purpose . . . by means that were outside of the usual course of professional medical practice and without a legitimate medical purpose,” all in violation of federal law.

Mach and Smith, one of the world’s most prolific e-mail spammers, forged together various enterprises, usually through spam e-mails, Internet sites and telemarketing call centers, according to the indictment. Beginning around July 2004 and for about a year, those operations exceeded $20 million in sales, authorities said.

During that span, Mach issued prescriptions for medicines including Xanax, an anxiety-reducing drug; Ambien, prescribed for insomnia; Cialis, an erectile-dysfunction drug, and Lipitor, which lowers cholesterol, to customers all over the country.

According to the indictment, Mach, as the sole acting physician in Smith’s enterprises, approved hundreds of prescriptions a day and “in virtually all instances” had no contact with either customers or their primary-care doctors. New Jersey requires that a doctor perform a physical examination of every patient before a prescription is written.

The indictment also stated that Mach issued scripts, including scripts for controlled substances, without verifying customers’ complaints, obtaining medical records or monitoring the customers’ response to the medications. Mach kept no records of his consultations, authorities said.

Mach was first licensed to practice medicine in New Jersey in July 1988, according to the state Division of Consumer Affairs. The division’s online profile for Mach also lists his initial license date as 1981 but does not specify which state issued that license. The U.S. Attorney’s Office noted that he has an inactive license issued in Pennsylvania.

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Erectile Dysfunction Drugs Prove Effective, Safe for Men With Diabetes

February 8, 2007

Popular drugs used to treat erectile dysfunction — Viagra, Levitra and Cialis — are safe and effective for men with diabetes, a new review has found.

The introduction of the medications known as phosphodiesterase type 5 (PDE-5) inhibitors to the market has changed the way physicians manage their patients with erectile dysfunction. The drugs have been shown to be quite effective in treating the condition in the general population and the number of men requesting them has soared in recent years.

The aim of the systematic review, however, was to determine whether PDE-5 inhibitors such as sildenafil (Viagra), vardenafil (Levitra) and tadalafil (Cialis) are also a safe and effective option for men with diabetes. Although diabetes can causes a variety of other chronic complications, such as heart disease and high blood pressure, PDE-5 inhibitors were shown not to cause many adverse reactions in this group.

At the end of the studies, men who took PDE-5 inhibitors showed improvements on all measures of erectile function, with an average difference of 26.7 percent more “successful intercourse attempts” compared to placebo groups.

The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates research in all aspects of health care. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing trials on a topic.

“The results of our meta-analysis are not surprising, but give strength to the general notion that this class of drugs is efficient and safe for this specific wide population,” said lead author Moshe Vardi, M.D., with the internal medicine division at Lady Davis Carmel Medical Center in Israel.

The Cochrane reviewers analyzed eight studies that compared the effectiveness of the three PDE-5 medications to placebo. A total of 1,759 men were recruited — with roughly half randomized to receive PDE-5 inhibitor therapy and the rest to the placebo group. Overall, 80 percent of the participants had type 2 diabetes and the others had type 1 diabetes.

Most of the studies lasted for 12 weeks, with no significant differences among treatment groups with regard to age, medical history, other prescribed medications or severity or duration of diabetes or erectile dysfunction.

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Erectile dysfunction is defined as the repeated inability to get or maintain an erection firm enough for sexual intercourse. According to the National Institute of Diabetes and Digestive and Kidney Diseases, men who have diabetes are three times more likely to have erectile dysfunction than men who do not have diabetes.

Taken an hour before sexual activity, PDE-5 inhibitors work by enhancing the effects of nitric oxide, a chemical that relaxes smooth muscles in the penis during sexual stimulation and allows increased blood flow.

“PDE-5 inhibitors have been considered the mainstay of treatment for erectile dysfunction in the general population for many years,” said Vardi. “Diabetics are prone to this complication, and the etiology of their erectile dysfunction is multifactorial, thus making their treatment a special challenge for physicians and other health care professionals.”

No deaths were reported in any of the included trials; the most common side effects for men in the treatment groups were headache, flushing and upper respiratory tract complaints and flu-like symptoms. The overall risk for developing any adverse reaction was 4.8 times higher in the PDE-5 group than in the control group.

As with any drug therapy, the Cochrane reviewers caution that men should use PDE-5 inhibitors only as directed by their physicians.

“These drugs can be taken on an ‘as needed’ basis, as their half-life spans from several hours to 48 hours at most,” said Vardi. “Patients should also consult their physicians for drug-drug interactions and specific contraindications.”

While this review supports the short-term safety of these medications for men with diabetes, experts say as yet there is no concrete evidence whether these medications are safe for the long term.

“I prescribe PDE-5 inhibitors every day to people with diabetes,” said John Buse, M.D., director of the Diabetes Care Center at the University of North Carolina School of Medicine. “But whether they are safe [in the long term] is the essential quandary of all medical care. We make our best guesses based on imperfect information, hopes and fears. And then we monitor progress. I am impressed that patients with diabetes in my practice in 2006 are living much better lives and perhaps longer lives than they did 10 years ago.”

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When market forces are no-shows

February 5, 2007

Health and Human Services Secretary Mike Leavitt makes a great argument for market forces being the most appropriate mode of control in setting prescription drug prices for the relatively new Medicare prescription drug benefit. Unfortunately, Leavitt’s argument, and the government’s position of not negotiating with drug manufacturers because of free-market forces, is as hypocritical as the day is long.

As an independent manufacturer’s representative with about 15 years experience selling equipment to the health-care industries, I have seen my fair share of government hypocrisy, but it’s been quite some time since the hypocrisy was this blatant on one particular issue.

Prescription medicines are prepared and dispensed for patients/consumers by pharmacists. Pharmacists are paid a reimbursement by Medicare for the privilege of dispensing medications, a reimbursement commonly referred to as the “dispensing fee.” What is most interesting (and hypocritical) about the government’s position is the fact that it is the government itself — i.e. Medicare — that sets or determines what these reimbursement rates are. In other words, the very government agency that Secretary Leavitt says should not be in the business of setting drug prices does precisely that, only it does it at the dispensing level not at the manufacturing level.

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If, for example, the mom and pop pharmacy down the street wants to differentiate itself from “the big boys,” and wants to install a patient consultation area or provide some other “above and beyond” service, it will have to pay to provide that service without reimbursement.

Medicare cuts dispensing fee reimbursements on an almost annual basis, in many cases to the point where a pharmacy can no longer afford to employ the kind of staff it needs to attend appropriately to patients’ needs. If free-market forces are good enough to determine drug prices without government interference at the manufacturing level, why are the same market forces not adequate to set prices at the dispensing level?

The answer, of course, is that big pharma writes much bigger checks to fill campaign and re-election coffers than the local mom and pop pharmacy does. I already know that we all have to live with the fact that the current administration in Washington, and in particular the puppet Congress of the past six years, has sold out our country to the “military-industrial complex.” I just can’t lie down silently when that very same government is blatant and in-your-face hypocritical about what it’s done.

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Lilly Announces 2006 Adjusted EPS of $3.18 Excluding Charges and Reported EPS of $2.45

February 2, 2007

Fourth-Quarter Highlights
* Sales increased 9 percent, to $4.245 billion.
* Newer products — Alimta(R), Byetta(R), Cialis(R), Cymbalta(R),
Forteo(R), Strattera(R), Symbyax(R), Xigris(R) and Yentreve(R) –
collectively grew 41 percent, to $1.120 billion, and accounted for 26
percent of total sales, compared with 20 percent of total sales in the
fourth quarter of 2005.
* Net income and earnings per share were $132.3 million and $.12,
respectively, compared with fourth-quarter 2005 net income of $700.6
million and $.64 earnings per share.
* Excluding certain charges in the fourth quarters of 2006 and 2005, net
income and earnings per share grew 7 and 6 percent, respectively, to
$929.6 million and $.85.

Significant Events Over the Last Three Months
* On January 29, 2007 Lilly completed the acquisition of ICOS Corporation
at a cost of approximately $2.3 billion. The acquisition brings the full
value of Cialis to Lilly and enables the company to realize operational
efficiencies in the further development, marketing and selling of this
product. Lilly expects the acquisition to be accretive to earnings
beginning in 2008.
* The United States Court of Appeals upheld an earlier ruling affirming
the validity of Lilly’s patent on Zyprexa through 2011.
* Lilly entered into agreements with plaintiff’s attorneys to settle the
vast majority of remaining product liability litigation claims regarding
Zyprexa. While the company believes the claims are without merit, it
took this step because Lilly believes it is in the best interest of the
company, the patients who depend on this medicine, and their doctors.
The settlements cover over 18,000 claims, and resulted in a charge in
the fourth quarter of 2006 of $494.9 million pre-tax, or $.42 per share.
* As part of Lilly’s ongoing efforts to increase productivity and reduce
its cost structure, the company reached decisions to close its
manufacturing facility in Basingstoke, England, and its research and
development sites in Belgium and Germany. A decision was also made to
stop construction of the planned insulin manufacturing facility in
Prince William County, Virginia. The combination of these decisions, and
other asset impairments, resulted in a fourth quarter 2006 charge of
$450.3 million or $.31 per share. In addition, the company announced a
voluntary exit program for up to 250 employees at its Tippecanoe
manufacturing site in Lafayette, Indiana.

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* In late November, Lilly and its partner Amylin received European
Commission authorization to market Byetta as a treatment for type 2
diabetes. In addition, in late December, Lilly and Amylin received U.S.
FDA approval for Byetta as an add-on therapy to improve blood sugar
control in people with type 2 diabetes who have not achieved adequate
control on a thiazolidinedione (TZD).
* In November, Lilly submitted a new drug application to the FDA for
Evista for the reduction in risk of invasive breast cancer in
postmenopausal women with osteoporosis and postmenopausal women at high
risk for breast cancer. Evista is currently indicated for the treatment
and prevention of osteoporosis in postmenopausal women.
* In late December, Lilly closed the enrollment of a Phase III study of
enzastaurin for the treatment of recurrent glioblastoma after an
external data monitoring committee determined the study would likely not
meet its primary endpoint. However, other enzastaurin trials are
ongoing, including a phase III study as a maintenance therapy to prevent
relapse in non-Hodgkin’s lymphoma patients and an earlier phase study
for frontline glioblastoma.
* In early January of 2007, Lilly licensed from OSI Pharmaceuticals its
glucokinase activator (GKA) program for the treatment of Type II
diabetes, including the lead compound PSN010. Lilly received an
exclusive license to develop and market any compounds derived from the
GKA program.
* In mid-January, Lilly, along with its partner Daiichi Sankyo, announced
that enrollment had been completed in the TRITON study, a phase III
head-to-head study comparing prasugrel to clopidogrel in patients with
acute coronary syndrome undergoing percutaneous coronary intervention
(PCI).
* In mid-January, Lilly announced the launch of a new business group
focused on companion animal health. The group, evolving at Lilly for
more than seven years, will produce innovative medicines for dogs and
cats under the Lilly brand name.

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