Close Concerns Weblog

Color coded insulin packaging? Outstanding idea!

Simple ideas usually work the best.

 

Lilly recently announced the launch of their color differentiation system for their U-100 insulin products in the United States (think Humalog® and Humalin®). Our thought? EXCELLENT idea! We're glad to see it and not a moment too soon. We know there are plenty of people with diabetes who have accidentally used the wrong type of insulin. Some have put long-acting insulin in pumps; others have given 15 units of Humalog instead of Lantus without realizing; etc. But beyond the normal mistakes people can make (young and older alike), remember that there are many people in the United States that have problems understanding the doctor's instructions. Health literacy can be as much of an obstacle to diabetes management as access to insulin in the United States. It's definitely a problem we should be working on equally while researching for a cure as part of the care to keep everyone healthy while we wait!

We give a thumbs up to these improved safety measures that will help patients use insulin correctly. Remember, it's important to always look at the label and read it correctly, follow your doctor's orders, etc. and we are glad for the extra recognition factor to assist in correctly identifying insulin. Lilly plans to introduce the color differentiation system in all insulin products, from vials to pens to individual packaging. This follows Lilly's 2004 introduction of bar coding of packaging and insulin vials. The color system will be introduced throughout 2008 with colors indicating both insulin 'family' and insulin 'type' (burgundy for Humalog; blue for Humalin; yellow for Regular; insulin mixes will have two colors).


What do you think are other ways to address the health literacy obstacle to diabetes management?

10/29/2008 in Diabetes - pharma | Permalink | Comments (1) | TrackBack (0)

Januvia May Have Some Company in the DPP-4 Inhibitor Arena in the US (it already does in the EU!)

For people with type 2 diabetes, choosing the right treatment option can be very difficult given the sheer number of diabetes drugs that are available. But patients in the US who want to try using a relatively new class of drug called a DPP-4 inhibitor have two options today: Januvia or Janumet (Januvia combined in one pill with metformin), both manufactured by Merck. This may change as other companies move their own DPP-4 inhibitors forward. [For a more in depth discussion about incretins and the DPP-4 inhibitor class, see Learning Curve in the latest issue of DiaTribe.]

Continue reading "Januvia May Have Some Company in the DPP-4 Inhibitor Arena in the US (it already does in the EU!)" »

02/11/2008 in Diabetes - pharma | Permalink | Comments (0)

Avandia in the news again

Check out our Revolution Health blog on what the Institute for Clinical Evaluative Sciences (ICES) had to report on Avandia use in older popultions. ICES published their report in the Journal of the American Medical Association (JAMA) issue dated December 12th 2007.

12/14/2007 in Diabetes - pharma | Permalink | Comments (0)

Like TZDs but no weight gain? InteKrin's new drug has intriguing prospects


On January 10th, the private biopharmaceutical company InteKrin Therapeutics, founded only two years ago and focused on metabolism and diabetes, announced that they had licensed a promising new drug for type 2 diabetes from Amgen. This drug – known now as INT131, formerly AMG131 – acts as an insulin sensitizer, through the same mechanism as TZDs, but is said to be without the weight gain and edema commonly associated with them. This may be very promising for people with insulin resistance (a huge percentage of people with type 2), and could be useful in preventing diabetes in people with pre-diabetes, an area we think will be increasingly important this decade. An anti-diabetes drug without side effects sounds great, as long as weight gain isn't part of the mechanism that is making it work, like it is said to be with Actos and Avandia (which together garnered well over $4 billion in sales last year)...

We haven't seen confirmatory data, and we're eager to.

By way of background - this drug had been part of Amgen's acquisition of Tularik awhile back - just as we were thrilled to see Amylin buy outright the Leptin portfolio from Amgen, especially since they are so much better equipped to take advantage of it (to us, Amylin has the most promising obesity pipeline out there, full stop), we are excited to see another company take a diabetes compound from Amgen, simply because it undoubtedly will receive more attention and notice and work. Doubters say that the "no-side-effect PPARs" won't have the potency that Actos and Avandia do - we think it's too early to say but we imagine the data has been quite promising, given the interest in InteKrin from early potential investors.

More good news came the next day, when the company announced that they'd received enough financing from investors to take the drug through phase 2 trials. The financing was led by a slew of smart investors, including Soffinova Ventures and Orbimed Advisors, which should be a great advantage for the young company. Equally impressive (and undoubtedly related) is InteKrin's scientific advisory board -- the board includes, for example, Stanford's Dr. Gerry Reaven, who is the father of metabolic syndrome, having identified a group of symptoms caused by insulin resistence in the late 1980s as "Syndrome X" and having given the American Diabetes Associations's prestigous Banting Lecture on the topic in 1988. Also on the board is Dr. David Orloff, formerly head of the FDA diabetes division - could there be anyone more informed to give good clinical trial advice? Dr. Orloff also has very impressive experience at CMS, so he'll know what the payors need to see - judgment that is more and more important over time.

Indeed, exciting. With all the options for type 2 oral medications, side effects (or lack thereof) may prove to be quite important, especially for drugs suitable for combination therapy. Today, only one class, thiazoladinediones, really work on insulin resistance, and we see this as an important mechanism for combination therapy - this should be a very interesting company to watch.


More in the press release below:

January 10 2007
InteKrin Therapeutics Licenses Diabetes Product
Novel Phase II Insulin Sensitizer

PALO ALTO, Calif. - January 10, 2007 -- InteKrin Therapeutics, Inc., a privately held clinical stage biopharmaceutical company focused on the development of products for diabetes, metabolism and obesity, announced today that it has entered into a license agreement with Amgen Inc. under which InteKrin has obtained worldwide development and commercialization rights to Amgen's PPAR gamma selective modulator and partial agonist, INT131. Formerly known as AMG131 and first developed by Tularik, Inc., this compound utilizes a well-validated and potent target for the treatment of diabetes and insulin resistance.

"We are very excited to pursue the further development of this promising compound for Type II diabetes. INT131 was specifically designed to dial-out side effects while still delivering high efficacy" remarked InteKrin's President and CEO Denny Lanfear. "This molecule is a good example of the type of scientifically superior compound InteKrin will be focused on as it further develops its portfolio."

"Based on the clinical data generated to date, we believe INT131 has the potential to become a highly effective therapeutic for the treatment of Type 2 diabetes, without the weight gain and edema seen with existing therapies." commented InteKrin Co-Founder Christos Mantzoros, M.D., DSc, of Harvard Medical School, "We are looking forward to completing the clinical development program and getting this important product to patients. We expect that its therapeutic profile may also be useful in pre-diabetes, helping patients delay the onset of the disease."

According to a June 2005 analyst report by Merrill Lynch, about 40 million people in the United States have pre-diabetes. An additional 18 million people in the U.S. currently have Type II diabetes, with 1.3 million new diagnoses each year. Morgan Stanley corroborates the magnitude of diabetes, predicting a drug market of $35 billion by 2012, up from $17 billion in 2005.

About InteKrin
InteKrin Therapeutics, Inc. is a privately-held clinical stage biopharmaceutical company based in Palo Alto, California developing therapeutics for diabetes, obesity and metabolic disorders. The company was founded in 2005 by Denny Lanfear, former Amgen Vice President and Officer, and Christos Mantzoros, M.D., DSc, renowned clinical endocrinologist and Associate Professor of Medicine at Harvard Medical School. InteKrin's Scientific Advisory Board includes veterans from several successful biopharmaceutical organizations, internationally recognized experts in nuclear receptors and metabolism as well as top scientists formerly with the Food and Drug Administration. The company focuses on high value therapeutics in addressing unmet medical needs. To learn more about InteKrin, visit www.intekrin.com.

01/13/2007 in Diabetes - pharma | Permalink | Comments (1)

Novo hires star Dr. Nathaniel Clark

As we noted in our newsletter Diabetes Close Up in mid-December, Novo was fortunate enough to hire Dr. Nathaniel Clark as part of its management team as a senior medical advisor last December. Dr. Clark was formerly vice president for clinical affairs at the ADA and has also worked with federal health agencies such as the U.S. Department of Health and Human Services and the CDC.

We think Novo’s pursuit of top talent is highly admirable. The company will provide a broad platform for Dr. Clark, who pursue and lead work in a range of important areas including insulin, GLP-1, and insulin pens, among others (likely more ininsulin delivery). Dr. Clark will also advise on several of Novo’s outreach initiatives, including its National Changing Diabetes Program and the DAWN Youth Program. The press release is below.

1. Novo Nordisk Appoints Nathaniel Clark, M.D., as Senior Medical Advisor - Diabetes Wednesday January 10, 9:06 am ET Former American Diabetes Association leader brings clinical expertise and health policy expertise to help Novo Nordisk in Changing Diabetes PRINCETON, N.J., Jan. 10 /PRNewswire/ -- Novo Nordisk, the world's leading diabetes care company, today announced the appointment of Nathaniel Clark, M.D., as senior medical advisor in the company's U.S. diabetes division. In this newly created position, Dr. Clark will provide medical leadership for key Novo Nordisk programs designed to improve patient outcomes. Dr. Clark most recently served as vice president for clinical affairs at the American Diabetes Association (ADA), working closely with leading healthcare organizations as well as federal agencies such as the U.S. Department of Health and Human Services and the Centers for Disease Control. This experience will serve Dr. Clark in his role at Novo Nordisk, where he will provide medical leadership as an advisor for such initiatives as the company's National Changing Diabetes Program, the DAWN Youth Program, and other partnership and association initiatives. "Dr. Clark comes to Novo Nordisk with an extensive background in both clinical guidelines and healthcare policy," said Alan Moses, M.D., associate vice president of medical affairs, Novo Nordisk. "We at Novo Nordisk are fortunate to have someone of Dr. Clark's caliber to help convert our passion for changing diabetes into programs and approaches that will fulfill the needs of healthcare providers for the benefit of people with diabetes." "I share Novo Nordisk's commitment to changing diabetes and look forward to taking part in its efforts to improve the experience and treatment of people living with the disease," said Dr. Clark. "In my new role, I hope to ignite new energy to help advance the company's innovative diabetes programs." Prior to the ADA, Dr. Clark joined the Joslin Diabetes Satellite Clinic on Cape Cod, where he served as associate director of diabetes services and director of pediatric services. He has worked as a staff endocrinologist in the Division of Endocrinology and in Pediatrics at the University of Vermont in Burlington and as director of the Vermont Regional Diabetes Center of Fletcher Allen Health Care. Well-versed in the intricacies of diabetes care, Dr. Clark also holds a Master's degree in nutrition and became a registered dietitian prior to graduating with a medical degree from the University of Massachusetts Medical School. He completed a combined pediatric and internal medicine residency at Baystate Medical Center in Springfield, Massachusetts, where he remained as an endocrinology fellow. Novo Nordisk is a healthcare company with an 83-year history of innovation and achievement in diabetes care. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. With headquarters in Denmark, Novo Nordisk employs more than 23,000 employees in 79 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For global information, visit novonordisk.com; for United States information, visit novonordisk-us.com.

01/10/2007 in Diabetes - pharma | Permalink | Comments (0)

More payouts from Lilly and more questions (16% of patients in clinical trial gained over 66 pounds each ...)

Eli Lilly and its top-selling drug Zyprexa (olanzapine) hit the news again yesterday with a major payout to people who had been affected aversely by the drug. Following closely on the heels of an article in The New York Times on a patient on Zyprexa who died after massive weight gain (see our discussion on “Eli Lilly under more fire with Zyprexa,” Jan. 4, 2007), the Times reported yesterday that Lilly will be settling some 18,000 lawsuits for a combined $500 million. In other words, that’s almost $28,000 per lawsuit. While not close to the scale of their previous payout last year ($87,500 per lawsuit), this development nevertheless represents yet another setback for Lilly’s defense of Zyprexa as a safe treatment for psychosis. It brings Lilly’s total settlements on Zyprexa’s account to a remarkable $1.2 billion.
Yesterday’s settlements mostly involved patients who claimed that they developed diabetes and other illnesses after taking Zyprexa to treat schizophrenia and bipolar disorder. We mentioned in our recent entry on Lilly that a 2002 analysis established a link between Zyprexa and heart disease, and it now appears increasingly likely that diabetes will be termed another official side effect of the drug. According to the Times, clinical trials have shown “that in many patients, Zyprexa also causes severe weight gain and increases in cholesterol and blood sugar.”
While for many who follow the industry, that’s old news, what is striking is this: Lilly hopes in the future to avoid similar lawsuits while continuing to market Zyprexa. Apparently, the reason for the reduced value of yesterday’s settlements (a drop of nearly $60,000) was a FDA label change for Zyprexa. Lilly now maintains that it has, since the label change in 2003, been consistently warning doctors of the health risks that attend taking Zyprexa. (For Lilly’s press release on the settlements, see here.)
What does this mean for Zyprexa and the people that take it? For one thing, people with diabetes resulting Zyprexa will likely lose the legal recourse that those patients exercised yesterday. Many may face realities such as that of John Eric Kauffman, the bipolar disorder sufferer and Zyprexa dependent who eventually passed away from heart disease. The responsibility has now been shrewdly shifted from the pharmaceutical to the doctors prescribing medicine for patients with mental illness.
Some would ask whether there’s any need for a drug that is neither necessarily safer (not by a long shot) nor significantly more effective than its alternatives. The FDA may have changed the label, and now the question is efficacy compared to older compounds. A Washington Post article in April came to the conclusion that better drugs – than Zyprexa and its olanzapine competitors – are the real answer. Reductive, perhaps, but we imagine that ploughing that $1.2 billion into developing a new, improved drug may ultimately be more rewarding than paying off patients made sick by the current one. While we know that biopolar disorder is incredibly serious and that many patients would do anything to stay on Zyprexa – and that many have gone on and stayed on Zyprexa to their benefit – too, many haven’t. Did it really need to drag on from 1996 to 2003 to get a new label – and are patients really being informed of the risks? Here's to figures like 16% of patients gaining over 66 pounds each coming to surface earlier...

Thank you to the NYT and Alex Berenson for this excellent ongoing coverage.
++++

Lilly Settles With 18,000 Over Zyprexa
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By ALEX BERENSON
Published: January 5, 2007
Eli Lilly agreed yesterday to pay up to $500 million to settle 18,000 lawsuits from people who claimed they had developed diabetes or other diseases after taking Zyprexa, Lilly’s drug for schizophrenia and bipolar disorder.

Including earlier settlements over Zyprexa, Lilly has now agreed to pay at least $1.2 billion to 28,500 people who said they were injured by the drug. At least 1,200 suits are still pending, the company said. About 20 million people worldwide have taken Zyprexa since its introduction in 1996.

The settlement covers cases filed in state and federal courts by law firms or groups of firms for 18,000 clients, Lilly said. The federal suits have been overseen in Brooklyn by Judge Jack B. Weinstein of the Eastern District of New York.

The settlement will not affect continuing civil or criminal investigations of Zyprexa by state attorneys general and federal prosecutors.

Both Lilly and lawyers for plaintiffs said they were pleased with the agreement. With global sales of roughly $4.2 billion last year, Zyprexa is Lilly’s largest-selling drug and a major contributor to the company’s profits. Lilly shares were relatively flat after the settlement announcement. They rose 11 cents yesterday, to $52.36.

Zyprexa is the brand name for olanzapine, a potent chemical that binds to receptors in the brain to reduce psychotic hallucinations and delusions. Clinical trials show that in many patients, Zyprexa also causes severe weight gain and increases in cholesterol and blood sugar.

Documents provided to The New York Times last month by a lawyer who represents mentally ill patients show that Lilly played down the risks of Zyprexa to doctors as the drug’s sales soared after its introduction in 1996. The internal documents show that in Lilly’s clinical trials, 16 percent of people taking Zyprexa gained more than 66 pounds after a year on the drug, a far higher figure than the company disclosed to doctors.

The documents also show that Lilly marketed the drug as appropriate for patients who did not meet accepted diagnoses of schizophrenia or bipolar disorder, Zyprexa’s only approved uses. By law, drug makers may promote their drugs only for diseases for which the Food and Drug Administration has found the medicines to be safe and effective, though doctors may prescribe drugs in any way they see fit.

In response to questions about the information in the documents, Lilly has denied any wrongdoing and said it provided all relevant information to doctors and the F.D.A. Lilly has also said it did not promote Zyprexa for conditions other than schizophrenia or bipolar disorder.

In 2004, a panel of the American Diabetes Association found that Zyprexa caused diabetes more than other widely used antipsychotic drugs, in part because it tends to cause much more weight gain. But the F.D.A. has never made a similar finding. Instead, the F.D.A. added a warning in 2003 to the label of Zyprexa and other new antipsychotic drugs about their tendency to cause high blood sugar.

In 2005, a $700 million agreement covered 8,000 patients, and the company has made 2,500 individual settlements whose total value has not been disclosed, Lilly said. The 2005 settlement valued claims at about $90,000 a plaintiff, while yesterday’s agreement values claims at about $27,000 a plaintiff, at most.

The lower value for the new claims comes in part because of the F.D.A. label change, which has allowed Lilly to say that it adequately warned doctors of the risks of Zyprexa after 2003. The label change may also help to protect Lilly from future lawsuits, analysts and lawyers say.

In its statement, Lilly said the settlement did not change its view that Zyprexa is a safe and effective treatment for mental illness.

“We wanted to reduce significant uncertainties involved in litigating such complex cases,” Sidney Taurel, Lilly’s chief executive, said in the statement.

Richard Meadow, one of the lead lawyers for the plaintiffs, said the deal was fair to both sides. “Prolonging this litigation further is in no one’s best interest,” he said.

01/06/2007 in Diabetes - pharma | Permalink | Comments (0)

NYT on Lilly's Zyprexa - unsettling at best

Veteran New York Times reporter Alex Berenson wrote a piecing overview of Lilly in Sunday's paper, with another one following today (see both below) charging essentially that the insulin manufacturer ignored - and kept from doctors and nurses - the risks of Zyprexa and also that they encouraged broad off-label use of the medicne. I've always vaguely known about the association of Zyprexa and weight gain, but that 30% of those who take it gain 22 pounds or more - I had no idea the extent of the problem. That so many develop diabetes (direct effect assumed) on Zyprexa is bad but if Lilly tried to mask this, that is what is really unsettling. It will be interesting to see if another ax falls tomorrow.


December 17, 2006
Eli Lilly Said to Play Down Risk of Top Pill

By ALEX BERENSON
The drug maker Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers.

The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes.

Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004.

Zyprexa has become by far Lilly’s best-selling product, with sales of $4.2 billion last year, when about two million people worldwide took the drug.

Critics, including the American Diabetes Association, have argued that Zyprexa, introduced in 1996, is more likely to cause diabetes than other widely used schizophrenia drugs. Lilly has consistently denied such a link, and did so again on Friday in a written response to questions about the documents. The company defended Zyprexa’s safety, and said the documents had been taken out of context.

But as early as 1999, the documents show that Lilly worried that side effects from Zyprexa, whose chemical name is olanzapine, would hurt sales.

“Olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule,” Dr. Alan Breier wrote in a November 1999 e-mail message to two-dozen Lilly employees that announced the formation of an “executive steering committee for olanzapine-associated weight changes and hyperglycemia.” Hyperglycemia is high blood sugar.

At the time Dr. Breier, who is now Lilly’s chief medical officer, was the chief scientist on the Zyprexa program.

In 2000, a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes warned the company that “unless we come clean on this, it could get much more serious than we might anticipate,” according to an e-mail message from one Lilly manager to another.

And in that year and 2001, the documents show, Lilly’s own marketing research found that psychiatrists were consistently saying that many more of their patients developed high blood sugar or diabetes while taking Zyprexa than other antipsychotic drugs.

The documents were collected as part of lawsuits on behalf of mentally ill patients against the company. Last year, Lilly agreed to pay $750 million to settle suits by 8,000 people who claimed they developed diabetes or other medical problems after taking Zyprexa. Thousands more suits against the company are pending.

On Friday, in its written response, Lilly said that it believed that Zyprexa remained an important treatment for patients with schizophrenia and bipolar disorder. The company said it had given the Food and Drug Administration all its data from clinical trials and reports of adverse events, as it is legally required to do. Lilly also said it shared data from literature reviews and large studies of Zyprexa’s real-world use.

“In summary, there is no scientific evidence establishing that Zyprexa causes diabetes,” the company said.

Lilly also said the documents should not have been made public because they might “cause unwarranted fear among patients that will cause them to stop taking their medication.”

As did similar documents disclosed by the drug maker Merck last year in response to lawsuits over its painkiller Vioxx, the Lilly documents offer an inside look at how a company marketed a drug while seeking to play down its side effects. Lilly, based in Indianapolis, is the sixth-largest American drug maker, with $14 billion in revenue last year.

The documents — which include e-mail, marketing material, sales projections and scientific reports — are replete with references to Zyprexa’s importance to Lilly’s future and the need to keep concerns about diabetes and obesity from hurting sales. But that effort became increasingly difficult as doctors saw Zyprexa’s side effects, the documents show.

In 2002, for example, Lilly rejected plans to give psychiatrists guidance about how to treat diabetes, worrying that doing so would tarnish Zyprexa’s reputation. “Although M.D.’s like objective, educational materials, having our reps provide some with diabetes would further build its association to Zyprexa,” a Lilly manager wrote in a March 2002 e-mail message.

But Lilly did expand its marketing to primary care physicians, who its internal studies showed were less aware of Zyprexa’s side effects. Lilly sales material encouraged representatives to promote Zyprexa as a “safe, gentle psychotropic” suitable for people with mild mental illness.

Some top psychiatrists say that Zyprexa will continue to be widely used despite its side effects, because it works better than most other antipsychotic medicines in severely ill patients. But others say that Zyprexa appears no more effective overall than other medicines.

And some doctors who specialize in diabetes care dispute Lilly’s assertion that Zyprexa does not cause more cases of diabetes than other psychiatric drugs. “When somebody gains weight, they need more insulin, they become more insulin resistant,” Dr. Joel Zonszein, the director of the clinical diabetes center at Montefiore Medical Center in the Bronx, said when asked about the drug.

In 2003, after reviewing data provided by Lilly and other drug makers, the F.D.A. said that the current class of antipsychotic drugs may cause high blood sugar. It did not specifically single out Zyprexa, nor did it say that the drugs had been proven to cause diabetes.

The drugs are known as atypical antipsychotics and include Johnson & Johnson’s Risperdal and AstraZeneca’s Seroquel. When they were introduced in the mid-1990s, psychiatrists hoped they would relieve mental illness without the tremors and facial twitches associated with older drugs. But the new drugs have not proven significantly better and have their own side effects, said Dr. Jeffrey Lieberman, the lead investigator on a federally sponsored clinical trial that compared Zyprexa and other new drugs with one older one.

The Zyprexa documents were provided to the Times by James B. Gottstein, a lawyer who represents mentally ill patients and has sued the state of Alaska over its efforts to force patients to take psychiatric medicines against their will. Mr. Gottstein said the information in the documents raised public health issues.

“Patients should be told the truth about drugs like Zyprexa,” Mr. Gottstein said.

Lilly originally provided the documents, under seal, to plaintiffs lawyers who sued the company claiming their clients developed diabetes from taking Zyprexa. Mr. Gottstein, who is not subject to the confidentiality agreement that covers the product liability suits, subpoenaed the documents in early December from a person involved in the suits.

In its statement, Lilly called the release of the documents “illegal.” The company said it could not comment on specific documents because of the continuing product liability suits.

In some ways, the Zyprexa documents are reminiscent of those produced in litigation over Vioxx, which Merck stopped selling in 2004 after a clinical trial proved it caused heart problems. They treat very different conditions, but Zyprexa and Vioxx are not entirely dissimilar. Both were thought to be safer than older and cheaper drugs, becoming bestsellers as a result, but turned out to have serious side effects.

After being pressed by doctors and regulators, Merck eventually did test Vioxx’s cardiovascular risks and withdrew the drug after finding that Vioxx increased heart attacks and strokes.

Lilly has never conducted a clinical trial to determine exactly how much Zyprexa raises patients’ diabetes risks. But scientists say conducting such a study would be exceedingly difficult, because diabetes takes years to develop, and it can be hard to keep mentally ill patients enrolled in a clinical trial.

When it was introduced, Zyprexa was the third and most heralded of the atypical antipsychotics. With psychiatrists eager for new treatments for schizophrenia, bipolar disorder, and dementia, Zyprexa’s sales soared.

But as sales grew, reports rolled in to Lilly and drug regulators that the medicine caused massive weight gain in many patients and was associated with diabetes. For example, a California doctor reported that 8 of his 35 patients on Zyprexa had developed high blood sugar, including two who required hospitalization.

The documents show that Lilly encouraged its sales representatives to play down those effects when talking to doctors. In one 1998 presentation, for example, Lilly said its salespeople should be told, “Don’t introduce the issue!!!” Meanwhile, the company researched combinations of Zyprexa with several other drugs, hoping to alleviate the weight gain. But the combinations failed.

To reassure doctors, Lilly also publicly said that when it followed up with patients who had taken Zyprexa in a clinical trial for three years, it found that weight gain appeared to plateau after about nine months. But the company did not discuss a far less reassuring finding in early 1999, disclosed in the documents, that blood sugar levels in the patients increased steadily for three years.

In 2000 and 2001, more warning signs emerged, the documents show. In four surveys conducted by Lilly’s marketing department, the company found that 70 percent of psychiatrists polled had seen at least one of their patients develop high blood sugar or diabetes while taking Zyprexa, compared with about 20 percent for Risperdal or Seroquel. Lilly never disclosed those findings.

By mid-2003, Lilly began to change its stance somewhat, publicly acknowledging that Zyprexa can cause severe obesity. Marketing documents make clear that by then Lilly believed it had no choice. On June 23, 2003, an internal committee reported that Zyprexa sales were “below plan” and that doctors were “switching/avoiding Zyprexa.”

Since then, Lilly has acknowledged Zyprexa’s effect on weight but has argued that it does not necessarily correlate to diabetes. But Zyprexa’s share of antipsychotic drug prescriptions is falling, and some psychiatrists say they no longer believe the information Lilly offers.

“From my personal experience, at first my concerns about weight gain with this drug were very significantly downplayed by their field representatives,” said Dr. James Phelps, a psychiatrist in Corvallis, Or. ‘Their continued efforts to downplay that, I think in retrospect, was an embarrassment to the company.”

Dr. Phelps says that he tries to avoid Zyprexa because of its side effects but sometimes still prescribes it, especially when patients are acutely psychotic and considering suicide, because it works faster than other medicines.

“I wind up using it as an emergency medicine, where it’s superb,” he said. “But I’m trying to get my patients off of Zyprexa, not put them on.”

Drug Files Show Maker Promoted Unapproved Use

By ALEX BERENSON
Eli Lilly encouraged primary care physicians to use Zyprexa, a powerful drug for schizophrenia and bipolar disorder, in patients who did not have either condition, according to internal Lilly marketing materials.

The marketing documents, given to The New York Times by a lawyer representing mentally ill patients, detail a multiyear promotional campaign that Lilly began in Orlando, Fla., in late 2000. In the campaign, called Viva Zyprexa, Lilly told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.

A Lilly executive said that she could not comment on specific documents but that the company had never promoted Zyprexa for off-label uses and that it always showed the marketing materials used by its sales representatives to the Food and Drug Administration, as required by law.

“We have extensive training for sales reps to assure that they provide information to the doctors that’s within the scope of the prescribing information approved by the F.D.A.,” Anne Nobles, Lilly’s vice president for corporate affairs, said in an interview yesterday.

Zyprexa is not approved to treat dementia or dementia-related psychosis, and in fact carries a prominent warning from the F.D.A. that it increases the risk of death in older patients with dementia-related psychosis. Federal laws bar drug makers from promoting prescription drugs for conditions for which they have not been approved — a practice known as off-label prescription — although doctors can prescribe drugs to any patient they wish.

Yet in 1999 and 2000 Lilly considered ways to convince primary care doctors that they should use Zyprexa on their patients. In one document, an unnamed Lilly marketing executive wrote that these doctors “do treat dementia” but “do not treat bipolar; schizophrenia is handled by psychiatrists.”

As a result, “dementia should be first message,” of a campaign to primary doctors, according to the document, which appears to be part of a larger marketing presentation but is not marked more specifically.

Later, the same document says that some primary care doctors “might prescribe outside of label.”

Ms. Nobles said that the company had never promoted its drug for any conditions except schizophrenia and bipolar disorder. Older patients who seem to have dementia may actually have schizophrenia that has gone untreated, Ms. Nobles said.

Several psychiatrists outside the company said yesterday that they strongly disagreed with Lilly’s claim. Schizophrenia is a severe disease that is almost always diagnosed when patients are in their teens or 20s. Its symptoms could not be confused with mild dementia, these doctors said.

Zyprexa is by far Lilly’s best-selling product, with $4.2 billion in sales in 2005, 30 percent of its overall revenues. About two million people worldwide received it last year. Based in Indianapolis, Lilly is the sixth-largest American drug company.

The issue of off-label marketing is controversial in the drug industry. Nearly every company is under either civil or criminal investigation for alleged efforts to expand the use of its drugs beyond the specific illness or condition for which they are approved.

Lilly faces federal and state investigations over its marketing of Zyprexa. In its annual report for 2005, Lilly said that it faced an investigation by federal prosecutors in Pennsylvania and that the Florida attorney general’s office had subpoenaed the company “seeking production of documents relating to sales of Zyprexa and our marketing and promotional practices with respect to Zyprexa.”

Since Lilly introduced Zyprexa in 1996, about 20 million patients worldwide have received the drug, which helps control the hallucinations and delusions associated with schizophrenia and severe mania. But Zyprexa also causes weight gain in many patients, and the American Diabetes Association found in 2004 that Zyprexa was more likely to cause diabetes than other widely used drugs for schizophrenia.

Lilly says that no link between Zyprexa and diabetes has been proven.

As part of the “Viva Zyprexa” campaign, in packets for its sales representatives, Eli Lilly created the profiles of patients whom it said would be suitable candidates for Zyprexa. Representatives were told to discuss the patient profiles with doctors. One of the patients was a woman in her 20s who showed mild symptoms of schizophrenia, while another was a man in his 40s who appeared to have bipolar disorder.

The third patient was “Martha,” a widow with adult children “who lives independently and has been your patient for some time.” Martha was described as being agitated and having disturbed sleep, but without the symptoms of paranoia or mania that typically marked a person with schizophrenia or bipolar disorder.

Ms. Nobles said that Lilly had actually intended Martha’s profile to represent a patient with schizophrenia. But psychiatrists outside the company said this claim defied credibility, especially given Martha’s age. Instead, she appeared to have mild dementia, they said.

“It’d be very unusual for this to be a schizophrenic patient,” said Dr. John March, chief of child and adolescent psychiatry at Duke University medical center. “Schizophrenia is a disease of teenagers and young adults.” Dr. March serves on Lilly’s scientific advisory board.

Diagnostic criteria for schizophrenia include delusions, hallucinations, disorganized and incoherent speech, and grossly disorganized behavior. They also include so-called negative symptoms like social isolation and a flattening of the voice and facial expressions.

The documents also show that Lilly encouraged primary care doctors to treat the symptoms and behaviors of schizophrenia and bipolar disorder even if the doctors had not actually diagnosed those diseases in their patients. Lilly’s market research had found that many primary care doctors did not consider themselves qualified to treat people with schizophrenia or severe bipolar disorder.

The campaign was successful, the documents show. By March 2001, about three months after the start of Viva Zyprexa, the campaign had led to 49,000 new prescriptions, according to a presentation that Michael Bandick, the brand manager for Zyprexa, gave at a national meeting of Lilly sales representatives in Dallas. Mr. Bandick did not say how many of those new prescriptions were for older patients with dementia.

Over all, sales of Zyprexa doubled between 1999 and 2002, rising from $1.5 billion to $3 billion in the United States. In 2002, the company changed the name of the primary care campaign to “Zyprexa Limitless” and began to focus on people with mild bipolar disorder who had previously been diagnosed as depressed — even though Zyprexa has been approved only for the treatment of mania in bipolar disorder, not depression.

In a 2002 guide for representatives, Lilly presented the profile of “Donna,” a single mother in her mid-30s whose “chief complaint is, ‘I feel so anxious and irritable lately.’ ” Several doctors’ appointments earlier, she was “talkative, elated, and reported little need for sleep.”

Lilly’s efforts to promote Zyprexa to primary care doctors disturbed some physicians, the documents show. In August 2001, a doctor in Virginia sent an e-mail message to Lilly and the F.D.A., complaining about a presentation from a Lilly sales representative who had discussed the hypothetical Martha with him.

The representative “presented an elderly female patient who was presented to her physician by her family complaining of insomnia, agitation, slight confusion, and had no physical finding to explain her state,” the doctor wrote. The representative then suggested that the doctor prescribe Zyprexa.

“I inquired what Zyprexa was indicated for she then indicated that many physicians might prescribe an antipsychotic for this patient. I then asked for her package insert and read to her that her product was indicated for schizophrenia and bipolar mania — neither of which the presented patient had been diagnosed with,” the doctor wrote.

He added that he had never contacted the F.D.A. before but was “genuinely concerned about the promotion of this powerful drug to my peer community of primary care physicians outside of its approved and intended purpose.”

Tara Ryker, a spokeswoman for Lilly, said the company no longer uses “Martha” or “Donna” in its marketing. “We are constantly developing new promotional materials and new profiles,” she said.

The Zyprexa documents were provided to The Times by James B. Gottstein, a lawyer who represents mentally ill patients and has sued the state of Alaska over its efforts to force patients to take psychiatric medicines against their will.

Mr. Gottstein said yesterday that the information in the documents should be available to patients and doctors, as well as judges who oversee the hearings that are required before people can be forced to take psychiatric drugs.

“The courts should have this information before they order this stuff injected into people’s unwilling bodies,” Mr. Gottstein said.

Lilly originally provided the documents, under seal, to plaintiffs lawyers who sued the company claiming their clients developed diabetes from taking Zyprexa. Last year, Lilly agreed to pay $700 million to settle about 8,000 of the claims, but thousands more are pending. Mr. Gottstein, who is not subject to the confidentiality agreement that covers the product liability suits, subpoenaed the documents in early December from a person involved in the suits.

The “Viva Zyprexa” documents also provide color about Lilly’s efforts to motivate its sales force as they marketed Zyprexa — whose generic name is olanzapine — to primary care doctors.

At the 2001 meeting in Dallas with Zyprexa sales representatives, Mr. Bandick praised 16 representatives by name for the number of prescriptions they had convinced doctors to write, according to a script prepared in advance of the meeting. More than 100 other representatives had convinced doctors to write at least 16 extra prescriptions and thus “maxed out on a pretty sweet incentive,” he said.

“Olanzapine is the molecule that keeps on giving,” Mr. Bandick said.

12/18/2006 in Diabetes - pharma | Permalink | Comments (3)

Lilly discusses new GLP-1

It seems like Lilly's announcement today that they are working on a new GLP-1 compound should be taken more lightly. While this might very well be the next mega blockbuster one day, for now, it's just typical phase 1 research that has a pretty small chance of making it, just given normal pharma research odds. Many are focused on the implications for doctors, patients, Amylin - there aren't really any implications for anyone except that research will continue in this field because early drugs in the class have been so good. But there have been a lot of failures as well - some by Lilly - and we don't feel like Byetta is really even relevant to this research because Lilly came at it relatively late in the game. They brought some very The hard work was done! Given that, we don't know what this drug will look like, only that it'll be a very long time before we see any real results. To wit: the last two years, we have heard that the obesity pipeline at Lilly is "very promising" and we heard that again today - but we've seen no phase 1 or phase 2 data! Today they did allow we might see data next year. We had hoped to hear about a long-acting analog for Lilly, since this is where Sanofi and Novo have really taken so much share - no news on this front. In the meantime, with respect to GLP-1, we suspect, with all due respect, for now, that Lilly needs Amylin a lot more than the reserse. What we really hope is that Lilly is successful with the drive to get Arxxant approved, its retinopathy drug - we're very impressed they are putting up such a fight and hope so that it ends well. Otherwise, whether any company will do ressearch on drugs for micrcovasuclar complications is a real question - why would they!

12/07/2006 in Diabetes - pharma | Permalink | Comments (1)

NYT Kolata on moving straight to drugs

New York Times journalist Gina Kolata wrote a fantastic piece in today's paper about the fact that it's taken awhile, but we're finally moving faster... straight to drugs, for newly diagnosed patients with diabetes. This has taken a long time. At one point, the average time between diagnosis and first drugs for patients with type 2 diabetes was seven years. Now, highly respected Dr. David Nathan of Mass General advises doctors, start patients on metformin right away. Between (and in) the lines, basically he seems to be saying that so few people are successful on the diet and exercise regimen that patients should really, from a public healthcare perspective, be put on a drug straight away so that the diabetes is treated immediately after diagnosis. We see this as a postive for all diabetes therapies, since it's all about earlier, more aggressive therapy - and we love the idea of arresting the disease earlier and earlier in the disease process - anything to put the brakes on long term complications. Onward!

October 17, 2006
Prospects
When Advice on Diabetes Is Sound, but Ignored

By GINA KOLATA
Ask any diabetes specialist whether people can protect themselves from Type 2 diabetes through diet and exercise and the answer will be a resounding yes. It has been shown three times, in studies in three countries, one of them the United States.

Weight loss and exercise can do more than just stave off diabetes, diabetes specialists will tell you. They can result in lower blood pressure, lower levels of cholesterol, less sleep apnea, more vigor and, in general, a better life.

But if you ask how likely it is that people at high risk of diabetes will follow the advice to diet and exercise, or about using a drug instead, you will get a different sort of answer.

It is a classic conundrum in medicine: if doctors know that patients can help themselves without taking drugs, but they also know that patients are not likely to follow this advice, what should they do?

Should diabetes specialists even bother to advise patients to try helping themselves through diet and exercise first, before prescribing drugs?

A large federal study, completed several years ago, seemed to make a compelling case that they should. A third of its 3,234 participants were assigned to a low-fat, low-calorie diet and told to exercise for 150 minutes a week. The others were given a placebo or were given metformin, a diabetes drug available as an inexpensive generic.

After an average of three years, just 14.1 percent of those in the diet and exercise group had developed diabetes. In contrast, 28.9 percent of participants taking the placebo had diabetes, and 21.7 percent of those taking metformin.

But the diet and exercise program was nothing like what an ordinary person might expect. The participants got extensive individual counseling and group support, at a cost of $1,356 a person the first year and $672 in each subsequent year. Even so, they shed only about 12 pounds after four years, or 4 percent of their initial weight. Most were continuing with their exercise program, though. If a large health plan decided to offer the same program for its members at risk for diabetes, the plan’s price for every member would rise by 1 percent, said Dr. David Eddy, the medical director of Archimedes Inc., a health care consulting company. Over 30 years, 61 percent of the people at risk would develop diabetes, as compared with 72 percent if no such program were instituted.

Last month, another study showed that a newer diabetes drug, rosiglitazone, might be more effective than either metformin or diet and exercise. Over three years, it reduced the risk of developing diabetes by 60 percent in people with elevated blood sugar levels.

Both drugs are relatively safe. Patients may lose about five pounds if they take metformin; other than that its major side effect is gastrointestinal disturbances, like a sense of fullness or soft bowel movements. Patients may gain about five pounds with rosiglitazone, about half of which is from fluid retention. That increases the risk of heart failure in people with heart disease.

But with the drugs’ effectiveness in preventing diabetes, maybe, some specialists say, doctors will soon view blood sugar as they do blood pressure or cholesterol. As soon as they spot an abnormally high level, they will whip out their prescription pads.

Already, health authorities have ventured along that path. International treatment guidelines once said that the first step for patients with full spectrum Type 2 diabetes was to exercise and lose weight. Only after patients had tried that and utterly failed were doctors to prescribe drugs.

As of August, however, the guidelines have changed.

“We recommend starting patients on metformin immediately,” said Dr. David M. Nathan, who directs the diabetes center at Massachusetts General Hospital and is a member of the group that formulated the new guidelines. “Don’t start with lifestyle alone, even for newly diagnosed people. Most end up failing the lifestyle recommendations.”

He added: “What classically happened was that the patients would take three months and try to diet. It wouldn’t work. Then they joined a health club. It didn’t work. Then they take another three months and try some more. By the time they were on effective therapy, they had had diabetes for years and years.”

In developing the new guidelines, the group reasoned that the consequences of untreated diabetes — which can include heart attacks, strokes, kidney failure, blindness and amputations — are too dire to allow high blood sugar levels to persist.

But that does not necessarily mean that drugs should be the first choice for people with so-called prediabetes, who have elevated blood sugar levels but have not yet developed the disease.

Or so says Rena Wing, a professor of psychiatry and human behavior at Brown University Medical School. Dr. Wing helped develop the diet and exercise program for the federal study of prediabetes.

Drugs, she said, should be a last resort for people with prediabetes. The answer to the problem of poor compliance with diet and exercise programs is to develop better ways of encouraging people to follow them, she said.

“If you have a problem that can be solved with a lifestyle change, you have to work on how to do that, how to bring it to people,” Dr. Wing said. “We have to change the system.”

For example, she said, there could be lists of effective programs for weight loss and exercise so doctors would stop telling patients to simply “lose weight” and say instead, “Join this program.”

Yet, if people know that a drug can solve their problem, how much incentive is there to change their diet and exercise patterns?

“The behaviorists say that if you have a medication available, you can hang up the idea that the patients will try lifestyle,” Dr. Nathan said.

Still, he said, “as a realist, it seems to me that the truth is that whatever your thoughts are on the importance of self-control and willpower and profligacy, and that we shouldn’t be such pigs, that we should exercise more, the truth is that we are what we are.”

Dr. Nathan added, “We have recognized that although lifestyle can be miraculously effective, it often isn’t, because people won’t change.”

10/17/2006 in Diabetes - pharma | Permalink | Comments (0)

EASD Part 2: DREAMing on ...

EASD Day #2

Kelly here. I woke up so excited today, as if I knew ahead of time how many stars the day could hold! It was not disappointing for a second.

One thing that is good about Copenhagen – they don’t have decaffeinated coffee here.  At least, I asked the bartender it tonight, and got a look like he thought I was crazy! I should have known they are too cool and style-y here to even consider having decaf around. It’s good, because the meeting is exhausting. One doesn’t want to miss a microsecond ...

So we wrote yesterday about the big-picture themes that have played into EASD so far – the intensifying focus on reduced glycemic variability, the increased post-prandial focus, the focus on earlier, more aggressive therapy, the focus on and the interest in avoiding complications, the growing disinterest in treating complications (granted they won’t disappear, but people really do want to avoid them altogether rather than just trying to treat), the move ever more toward reduced treatment targets, the evolving treatment pathways, the interest in more optimized outcomes, the intense interest in beta cell health, the interest in achieving normalcy. Or, better than normalcy.

Every day I find diabetes interesting, but every day, I don’t necessarily like being part of it. Sometimes I would prefer being a little more on the outside looking in. But I liked being part of diabetes today – even if I’m not really part of it, per se, as in part of the solution.  Today, it seems there’s a feeling here that we can all do better – industry, doctors, patients. Doctors, patients, industry. Patients, doctors, industry. There’s a feeling here that we’re really doing pretty badly, that we won’t be able to fix everything at once, that many times we can't fix anything at once … (and I speak from the perspective of the US – try China) but that at least we should be trying and that we should be oh-so-completely going for it. We finally have some better tools, and it is just inspiring to watch, to say nothing of digging in.

So what I liked most of all today was the DREAM trial. I liked it not because of what it means commercially for GSK but because of what it meant for the disease. The PIs of this trial showed that they could change the course of this ravaging disease – what congratulations they deserve! They will look back, I hope, and be proud for moving forward the research that makes the world realize that it can be done.  Yes, DPP and Tripod really taught us it could be done – but this strengthened it.

The cynic says that lifestyle can reduce progression 58% and Avandia reduces risk by 60% so why would you even consider gaining modest weight with modest CHF risk and use Avandia and
forget lifestyle? For sure, no one is saying to forget lifestyle. But from a public health (or any) perspective, lifestyle obviously doesn't work so well - we need other tools so that we can continue to generate other trials.

DREAM is not done perfectly by any stretch and there are some truly unsettling aspects of the trial results. But, here is what we care about. Despite everything that remains uncertain, the initial results in our view are promising enough that they should make Merck, Novartis, BMS, Lilly, and J&J (who must be very excited about the recent Metabolex deal) and others realize that the ROI on prevention might well be positive – and that they better go for it because if they don’t, someone else will – and because prevention is the right thing to do for past, future, and present patients.

It’s a whole new world in terms of companies working on metabolic disease – onward! The results of DREAM can be found in about one zillion places online so I won’t focus on that too much here. Here are ten thoughts on the trial:

1. Results suggest that underlying physiology can be changed. It’s not just about glucose, and it’s not just about getting good numbers somewhat consistently. It’s about avoiding the disease. There was a 62% reduction in progression to diabetes for the rosiglitizone treated group (versus the treatment arm) – in real life, that means that 10.6% of the 5,279 people in the trial progressed to diabetes compared to 25% of people on placebo.
2. Even better BETTER yet – there was also  a return to real life (without diabetes) for people with pre-diabetes. Specifically, over half – half! – (51 percent) returned to normal blood glucose levels for the group, compared to about 30 percent of people on placebo. Amazingly to us this was seen after just a year, suggesting that other pre-diabetes trials mihgt well be faster than we had imagined.
3. In terms of safety, there were troubling results regarding congestive heart failure and weight gain. And, in a trial that people had hoped would provide cardiovascular benefits, none were seen.
4. 14 people in the study developed CHF who were in the treatment arm versus 2 in the placebo arm – that is a substantial difference in terms of relative risk, to be sure. The messaging seemed to focus more on “only 14 out of 5,279” than on relative risk.  The math says that if 10 percent of those in the US estimated to have impaired glucose tolerance and impaired fasting glucose were treated with TZDs, 130,000 cases of diabetes would be prevented, many thousands more would move back to normal from pre-diabetes, and 4,500 cases of CHF would occur. And this math reflects the low-risk population, so in a more real life population, it’s probably a higher number who would get CFH and maybe a lower rate who would qualify! 
5. Additionally, the weight gain seen by those treated with TZDs was an average 2.2 kg – while the placebo group lost a little weight  - so again, were this normalized, probably the weight loss would be higher. The PIs spoke a lot about how this is the “good” weight and we get that theoretically, but back in the real world, it still brings up an illusion of someone saying, looking at you funny, “So I have pre-diabetes and now you want me to take a drug that is going to make me gain weight?! And, it’s possible I might have a heart attack? More possible than otherwise? Um, what?”
6. Of course there are many questions: 1) How can we learn more about the CHF (there were no deaths, but no matter – we wouldn’t be at the point of examining death yet, after only three years); 2) Is it possible to minimize weight gain and CHF? 3)  How can we figure out the return on investment for the trial overall – we know avoiding risk overall is impossible, so it is just tradeoffs – which are the right ones?; 4) How is beta cell health? 5) What will GSK do - is this enough to submit to the FDA for registration for pre-diabetes? (We think not, because of all the safety concerns but we note a trial might not take as long as had been expected, perhaps two years.) 6) Will we see reimbursement?
7. One big bucket of questions concerns other diabetes companies.  We think the results of the trial are a major signal to big pharma invest further in pre-diabetes. We really like the idea of DPP4s and GLP-1 being tested for prevention (since safety and tolerability seem to have a better record) and we oh-so-LOVE the idea of LAR being considered for prevention. Who knows what they will find, but I love the idea of such a potentially fruitful investment because n=1, but I have this disease and I loathe it. I talk a lot about how having it gives me the chance to be healthier than I otherwise might be, and I think most days I am pretty legitimately glass half full about it. But I also think it's wrong to ignore that people with diabetes also actively or passively resent that their bodies betray them every single day. It’s all super sub-optimal once you have this disease, with or without complications. It’s all a continuum that you really don’t want to be on, however bright you can say things are.
8. So, let’s also not let some random statistician deciding to take away others’ chances of prevention just because of a signal we don’t even know yet is weak or positive.  Based on what we've seen, we'd say we would think it quite negative, but we're not so expert about that.
9.    Epidemiologist Dr. Nick Wareham did an amazing job of pointing out some of the risks and helping us think about potential safety signals, cost effectiveness, etc - and his last slide said it all "INDEPENDENT."
10. So speculation is rampant -  let’s not miss the forest for the trees. DEMAND is incredibly important work that has been done and it should be congratulated and taken oh-so-seriously – and then we should wait for more work on side effects – maybe they are enough to suggest people with pre-diabetes not take this, maybe they aren’t.  It would probably be best if we don’t behave like any of us knows yet. On that note, we can’t wait to see washout data in South Africa to see what sort of picture is there …

09/15/2006 in Diabetes - pharma | Permalink | Comments (0)

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