Serafem by drug3k

I have written at length about the “corporatization” of health care in the US and the campaign by pharmaceutical companies to “medicalize” depression, menopause and other common conditions to market drugs that supposedly treat them. thanks to skillful marketing, Eli Lilly has also turned premenstrual syndrome (PMS) into a profit-making commodity almost as lucrative as childhood bipolar disorder (a condition only recognized in the US).

In 1994, the American Psychiatric Association (APA) included premenstrual dysphoric disorder (PMDD) in their diagnostic manual as a “possible mental disorder requiring more research.” Although DSM IV lists PMDD as a strictly “research” diagnosis, Eli Lilly immediately seized on it as a genuine disorder and devised a marketing strategy to profit from it.

The Difference Between PMS and PMDD

Approximately 80-90% of women worldwide report physical and emotional changes in the 7-10 days prior to the onset of menstruation. For the majority of women, these consist of minor physical changes similar to those of early pregnancy (water retention, breast swelling and tenderness and abdominal bloating). Approximately 1/3 of women note mental and emotional changes (aka PMS) – depression, anxiety, fatigue, irritability, insomnia, difficulty concentrating – that have a minor impact on their daily functioning. Although the APA has yet to agree PMDD even exists as a disorder, there are numerous claims in psychiatric and women’s health literature that approximately 3-8% of women suffer from it. By definition, a woman can only qualify for a PMDD diagnosis if they experience a “marked” decrease in normal functioning due to premenstrual mood changes. a rigorous Swedish study recently ascertained that the true percentage of women experiencing a “marked” decrease in functioning before their period closer to 1.3% (nytimes.com/ref/health/healthguide/esn-pms-ess.html)

A Golden Marketing Opportunity for Eli Lilly

Once the patent on a drug expires, other manufacturers are free to produce much cheaper generic versions, resulting in plummeting sales of the original brand name drug. Lilly, who was facing the expiration of its patent (in 1999) on Prozac, exploited the inclusion of PMDD in the 1994 DSM IV by re-branding Prozac as a feminine pink and purple tablet called Sarafem. In 2001, the FDA approved Sarafem for “PMDD,” on the basis of double blind studies involving several hundred women. Lilly reported a 60% response rate in women who took it for five cycles, with greater effectiveness in women who took it continuously throughout the month (as opposed to 7-10 days before their period).

I found this high response rate really puzzling, given that 30 years of double blind studies using fluoxetine to treat depression have an average response rate of 38-40%. In fact statistical analysis of all randomized controlled reveal that the average response rate of all SSRI antidepressants (i.e. Prozac, Zoloft, Paxil, citalopram, etc) is only slightly higher than the placebo rate (33-37%). In fact as I have written previously (see “Marketing Serotonin Deficiency” opednews.com/articles/Marketing-Serotonin-Defici-by-Dr-Stuart-Jeanne-B-100713-513.html), there is no scientific evidence that serotonin deficiency (the alleged condition SSRI’s are prescribed for) actually causes depression.

Skillful Marketing: Adding Billions to the US Health Care Bill

Charging $3 per dose for their pink and purple Sarafem tablets (in contrast to 41 cents a pill per dose for generic fluoxetine), Lilly launched a massive marketing campaign to convince women they suffered from PMDD. In 2001, the year it came out, nearly 100,000 prescriptions were sold, reaping Lilly $85 million in profits. The high number of prescriptions suggests that doctors have been giving it out indiscriminately for premenstrual complaints, rather than limiting treatment to women with the severe symptoms allegedly associated with PMDD. Moreover given the soaring cost of health care in the US (the main reason millions of Americans do without medical care), it seems cynically immoral to trick doctors and women into wasting nearly a billion dollars on pink and purple pills with a fancy name, when generic fluoxetine would have been equally effective at 1/9 the cost.

After Lilly’s phenomenal success, psychiatrists and drug researchers seized on a handful of studies to claim that serotonin deficiency was the cause of both PMDD and PMS. This, in turn, led other SSRI manufacturers to jump on the bandwagon to get their drugs approved.

“Natural” and “Alternative” Treatments for Premenstrual Syndrome

What I find really fascinating about the PMS/PMDD controversy is that it’s one of the few women’s health “conditions” in which there are more double blind placebo trials of “alternative” or “natural” treatments than medication trials. The three “alternative” treatments that have shown clear effectiveness in randomized controlled trials are omega 3 supplements, megadose Vitamin D and the chaste tree berry.

Omega 3 oil is the most studied in PMS-related mood changes, largely owing to its proven efficacy in depression and large cross cultural studies revealing that populations (for example Asians and Norwegians) consuming large amounts of fish (a primary source of omega 3) in their diets have an extremely low incidence of depression.

Vitamin D, though less well studied in PMS, has also proved helpful for depression in double blind studies, especially in elderly depressives, many of whom suffer from documented Vitamin D deficiency. There are a handful of studies showing that 1,000 — 2,000 international units of Vitamin D (with or without calcium) is also helpful in alleviating premenstrual symptoms. I don’t believe this is a coincidence, given Asian women’s extremely low incidence of mood-related PMS. The same oily fish that are a rich source of omega 3 are the only natural food source of Vitamin D (the majority of us derive Vitamin D from a skin reaction triggered by exposure to sunlight).

Three double blind studies in the British Medical Journal, the Archives of Gynecology and Obstetrics and the Journal of Women’s Health and Gender-based Medicine reveal that chaste berry helps approximately 52% of women with PMS. Chaste berry is an herbal remedy used by Hippocrates in ancient Greece for premenstrual symptoms. It’s believed to work by lowering prolactin (a pituitary hormone influencing milk production). High prolactin levels are a recognized, but infrequent, cause of depression.

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Press Release Source: Amylin Pharmaceuticals, inc. On Thursday March 10, 2011, 8:00 am EST

SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., March 10, 2011 /PRNewswire/ — Amylin Pharmaceuticals, inc. (Nasdaq:AMLN – News), Eli Lilly and Company (NYSE:LLY – News) and Alkermes, inc. (Nasdaq:ALKS – News) today announced positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes.

(Logo:  https://photos.prnewswire.com/prnh/20101020/LA85062LOGO-a)

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The 121-patient, phase 2 study assessed the efficacy, safety and tolerability of three different doses of exenatide once monthly. it also assessed exenatide once weekly (exenatide extended-release for injectable suspension, proposed brand name BYDUREON™), another investigational type 2 diabetes therapy. after 20 weeks of treatment (five injections), patients randomized to the exenatide once monthly treatment arms experienced average reductions in A1C ranging between 1.3 and 1.5 percentage points from baseline. in the once-weekly BYDUREON treatment arm, the reduction was 1.5 percentage points. A1C is a measure of average blood sugar over three months.

“As innovators in the treatment of type 2 diabetes we brought the first GLP-1 product, BYETTA, to patients. we are now developing once-weekly and once-monthly formulations of exenatide to expand patient choices for improving glycemic control,” said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. “Based on the encouraging results of this study, we plan to proceed with regulatory interactions to outline the next steps for this important program.”

More than 90 percent of patients overall completed the study. The most common adverse events among the exenatide once monthly treatment groups were headache and nausea. Headache and diarrhea were most common among the once-weekly BYDUREON group. no major or minor hypoglycemia was reported in the study.

Exenatide once monthly is a new, extended-release formulation of exenatide, the active ingredient in BYETTA® (exenatide) injection, which is given twice daily. Exenatide once monthly is based on the same Medisorb® microsphere technology used in BYDUREON.

Study Design

This phase 2, randomized, open-label study included 121 adults with type 2 diabetes who were not achieving adequate glucose control using diet and exercise alone or with a stable regimen of metformin, Actos® (pioglitazone), or both.  Subjects were randomized to receive either 2 mg weekly subcutaneous injections of BYDUREON or subcutaneous injections of exenatide once monthly at a low, medium or high dose, each administered once every four weeks, for a total of 20 weeks.

About Diabetes

Diabetes affects nearly 26 million people in the U.S. and an estimated 285 million adults worldwide.(i, ii)  Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes costs approximately $174 billion per year in direct and indirect medical expenses.(iii)

According to the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv) in addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(v) Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi, vii)

About BYETTA® (exenatide) injection

BYETTA was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone GLP-1. GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.

BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program. BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not currently recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis. BYETTA has not been studied in people who have pancreatitis.

BYETTA provides sustained A1C control and low incidence of hypoglycemia when used alone or in combination with metformin or a thiazolidinedione, with potential weight loss (BYETTA is not a weight-loss product). BYETTA was approved in the U.S. in April 2005 and has been used by more than 1.5 million patients since its introduction. see important safety information below. Additional information about BYETTA is available at BYETTA.com.

Important Safety Information for BYETTA® (exenatide) injection

Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Patients should be observed for signs and symptoms of pancreatitis after initiation or dose escalation of BYETTA. The risk for getting low blood sugar is higher if BYETTA is taken with another medicine that can cause low blood sugar, such as a sulfonylurea. BYETTA should not be used in people who have severe kidney problems and should be used with caution in people who have had a kidney transplant. Patients should talk with their healthcare provider if they have severe problems with their stomach, such as delayed emptying of the stomach (gastroparesis) or problems with digesting food. Antibodies may develop with use of BYETTA. Patients who develop high titers to exenatide could have worsening or failure to achieve adequate glycemic control. Consider alternative therapy if this occurs. Severe allergic reactions can happen with BYETTA. There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.

The most common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea most commonly happens when first starting BYETTA, but may become less over time.

These are not all the side effects from use of BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.

For additional important safety information about BYETTA, please see the full Prescribing Information (byetta.com/pi) and Medication Guide (byetta.com/mg).

About Amylin, Lilly and Alkermes

Amylin, Lilly and Alkermes are working together to develop extended-release formulations of exenatide, including once-weekly BYDUREON and exenatide once monthly.  Both formulations are subcutaneous injections of exenatide for the treatment of type 2 diabetes based on Alkermes’ proprietary Medisorb® technology. BYDUREON and exenatide once monthly are not currently approved by any regulatory agency.

Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin’s research and development activities leverage the Company’s expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego.

Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. since 1923, Lilly has been the industry leader in pioneering therapies to help healthcare professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs.

Alkermes, inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients’ lives. Alkermes’ robust pipeline includes extended-release injectable and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Waltham, Mass., Alkermes has a research facility in Massachusetts and a commercial manufacturing facility in Ohio.

This press release contains forward-looking statements about Amylin, Lilly and Alkermes. Actual results could differ materially from those discussed or implied in this press release due to a number of risks and uncertainties, including the risk that BYDUREON may not be approved by the FDA and/or the European Commission as soon as anticipated or at all; the companies’ response to the FDA’s complete response letter may not be submitted in a timely manner and/or the information provided in such response may not satisfy the FDA; the FDA may request additional information prior to approval; BYETTA and/or the approval of BYDUREON and the revenues generated from these products may be affected by competition; unexpected new data; safety and technical issues; clinical trials, including the trial mentioned in this press release, not being completed in a timely manner, not confirming previous results, not being replicated in future studies, not being predictive of real world use or not achieving the intended clinical endpoints; label expansion requests or NDA filings not receiving regulatory approval; the commercial launch of BYDUREON being delayed; or manufacturing and supply issues. The potential for BYETTA and/or BYDUREON may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the development and commercialization of pharmaceutical products including those inherent in the collaboration with and dependence upon Amylin, Lilly and/or Alkermes. these and additional risks and uncertainties are described more fully in Amylin’s, Lilly’s and Alkermes’ most recent SEC filings including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin, Lilly and Alkermes undertake no duty to update these forward-looking statements.

BYDUREON™ and BYETTA® are trademarks of Amylin Pharmaceuticals, inc., and Medisorb® is a registered trademark of Alkermes, inc. All other marks are the marks of their respective owners.

P-LLY

(i) Diabetes Statistics. American Diabetes Association. Available at: diabetes.org/diabetes-basics/diabetes-statistics/. Accessed March 10, 2011.

(ii) The International Diabetes Federation Diabetes Atlas. Available at: diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010. Accessed March 10, 2011.

(iii) Direct and Indirect Costs of Diabetes in the United States. American Diabetes Association. Available at: diabetes.org/how-to-help/action/resources/cost-of-diabetes.html.  Accessed March 10, 2011.

(iv) Saydah SH, Fradkin J and Cowie CC. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA. 2004;291:335-42.

(v) Bays HE, Chapman RH, Grandy S. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61:737-47.

(vi) Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007;30 Suppl 1:S48-65.

(vii) Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-9.

Alnara’s Pancreatic Enzyme Replacement Therapy, Liprotamase, currently Under FDA Review

Eli Lilly and Company and Alnara Pharmaceuticals, inc. recently announced they have signed a definitive merger agreement whereby Lilly will acquire Alnara, a privately held biotechnology company developing protein therapeutics for the treatment of metabolic diseases. Alnara’s lead product in development is liprotamase, a non-porcine pancreatic enzyme replacement therapy (PERT). Liprotamase is under review by the U.S. Food and Drug Administration for the treatment of exocrine pancreatic insufficiency (EPI). Causes of EPI include cystic fibrosis, chronic pancreatitis, pancreatectomy and other conditions.

Patients with pancreatic insufficiency cannot properly digest and absorb fat, protein, and carbohydrates — preventing adequate nutrient absorption. PERT is a treatment involving the administration of three pancreatic enzymes. EPI often is associated with cystic fibrosis, a life- threatening genetic disorder.

Cystic fibrosis affects approximately 30,000 children and adults in the United States and nearly 100,000 people worldwide. Approximately 90 percent of cystic fibrosis patients receive pancreatic enzyme replacement therapy to improve nutritional status and bowel-related symptoms related to pancreatic insufficiency.

Financial terms of the agreement are not being disclosed. The transaction is contingent upon clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. J.P. Morgan Securities inc. acted as the exclusive financial advisor to Alnara Pharmaceuticals and WilmerHale is serving as legal advisor to Alnara Pharmaceuticals.

“The acquisition of Alnara provides Lilly with a promising entry into enzyme replacement therapy — an area with unmet medical needs as well as opportunities for novel compounds that give patients additional treatment options,” said Bryce Carmine, executive vice president of Lilly and president of Lilly BioMedicines. “Alnara has been very successful in the development of liprotamase — as indicated by its recent submission to the FDA — and we look forward to partnering with Alnara’s experts during the regulatory review process.”

Alexey Margolin, Ph.D., chief executive officer of Alnara, said: “Our agreement with Lilly is an important development as we move liprotamase through FDA regulatory review. Lilly’s deep expertise in the U.S. pharmaceutical business, including regulatory affairs and the development of innovative compounds that address unmet medical needs, created a natural fit and could allow for opportunities in markets beyond cystic fibrosis. We look forward to finalizing the transaction and working together on next steps to bring liprotamase to patients.”

If approved, liprotamase will allow many patients to use significantly fewer pills compared to current treatment options. Treatments in the PERT class reduce malabsorption and enhance nutrition in patients with EPI. because it is not derived from a porcine source, liprotamase could provide the added benefit for patients of reduction in the risk of viral exposure. A pediatric formulation of liprotamase also is in development.

About Liprotamase & Pancreatic Enzyme Replacement Therapy (PERT) Liprotamase is an oral, non-porcine pancreatic enzyme replacement therapy designed to treat maldigestion, malabsorption and malnutrition as a result of exocrine pancreatic insufficiency associated with cystic fibrosis, chronic pancreatitis, pancreatic cancer, pancreatectomy and other pancreatic diseases. Patients with pancreatic insufficiency cannot properly digest and absorb fat, protein, and carbohydrates preventing adequate nutrient absorption. PERT is a treatment involving the administration of pancreatic enzymes, which in the case of liprotamase includes protease, amylase and lipase. Results from an international, Phase 3 open-label, long-term safety study presented at the North American Cystic Fibrosis Conference in October, 2009 demonstrated the safety and nutritional benefits of liprotamase. The nutritional parameters measured during the study showed nutritional maintenance relative to the U.S. population, as well as a significantly reduced pill burden.

About Alnara Alnara Pharmaceuticals, inc. is dedicated to developing and commercializing novel protein therapeutics for the treatment of metabolic diseases. The company’s innovative approach focuses on designing effective protein therapies that can be orally delivered directly to the gastrointestinal tract without being absorbed into the bloodstream. Alnara’s lead product is liprotamase, a novel, non-porcine pancreatic enzyme replacement therapy, which has completed Phase 3 clinical development in collaboration with the Cystic Fibrosis Foundation Therapeutics, inc. (CFFT) and is currently under review by the FDA. The company is committed to bringing breakthrough new treatments to patients with unmet medical needs. Alnara was co-founded in 2008 by Alexey Margolin, Rich Aldrich and Christoph Westphal. Based in Cambridge, Massachusetts, Alnara is backed by an experienced management team and top-tier venture investors, including Third Rock Ventures, Frazier Healthcare, MPM Capital, Bessemer Venture Partners and Longwood Founders Fund. for more information, visit alnara.com.

About Eli Lilly and Company Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. for more information, visit lilly.com.

SOURCE: Eli Lilly and Company & Alnara Pharmaceuticals, inc.

A new Roche drug that treats the listlessness and apathy experienced by schizophrenics is “the most exciting development in the therapeutics of schizophrenia in a long time,” according to a top psychiatry researcher.

The researcher, Columbia University’s Jeffrey Lieberman, is excited because the new medicine, RG1678, works entirely differently from the drugs that preceded it, was designed rationally, and treats symptoms of the disease that current entrants don’t address.

Lieberman played a pivotal role in testing current big selling schizophrenia drugs such as Eli Lilly’s Zyprexa, Pfizer’s Geodon and Bristol-Myers Squibb and Otsuka’s Abilify. But he also ran a large clinical trial, run by the National Institutes of Health, that has been widely interpreted as meaning that advantages of these drugs, known as second-generation antipsychotics, are more limited than doctors originally thought.

RG1687 is a glycine reuptake inhibitor. it inhibits the re-absorption of glycine, a important neurotransmitter, thereby normalizing levels of glutamate, another brain chemical thought to be important in schizophrenia. Experts have been discussing boosting glycine for more than a decade. Lieberman emphasizes that these drugs were developed “rationally, as opposed to serendipitously.”

However, Lieberman cautions, longer studies are going to be critical in proving if this drug works. Roche, which released the results in a press release, says that bigger clinical trials are being conducted with the hope of filing for regulatory approval.

Roche’s medicine is important not just because it works in a new way, but also because it treats symptoms of schizophrenia that other medicines don’t. Most drugs are targeted against the so-called positive symptoms of schizophrenia, the obvious, acute problems like hallucinations. RG1678 is being tested as a treatment for the negative symptoms of the disease, which include apathy and poor or nonexistent social functioning. these problems can be debilitating for schizophrenic patients, who experience them very frequently. Roche hopes that the first use of RG1678 will be in patients who are on other schizophrenia drugs, but who need relief from the negative symptoms of the disease.

Although Roche said that patients who did not withdraw from the study had a significant reduction in negative symptoms, the drug did have side effects. There was a panic attack, a suicide attempt, and a case of anxiety in the drug group, and there was a dose-dependent decrease in hemoglobin that was not considered clinically significant.

Globe and Mail UpdatePublished on Thursday, Aug. 19, 2010 4:24PM EDTLast updated on Friday, Aug. 20, 2010 9:29AM EDT

The failure of a promising Alzheimer’s drug in clinical trials highlights the gap between diagnosis – where real progress has recently been made – and treatment of the disease.

It was not just that the drug, made by Eli Lilly, did not work – maybe that could be explained by saying the patients’ illness was too far advanced when they received it. It was that the drug actually made them worse, the company said. And the larger the dose they took, the worse were patients’ symptoms of memory loss and inability to care for themselves. not only that, the drug also increased the risk of skin cancer.

So when Lilly announced Tuesday that it was ending its large clinical trials of that drug, semagacestat, researchers were dismayed.

“obviously, this is disappointing news, to say the least,” said Steven Paul, an Alzheimer’s researcher and a recently retired executive vice president at Lilly.

Beyond the setback for Lilly, the study raises questions about a leading hypothesis of the cause of Alzheimer’s and how to treat it. the idea, known as the amyloid hypothesis, says the disease occurs when a toxic protein, beta amyloid, accumulates in the brain. the idea is that if beta amyloid levels are reduced, the disease might be slowed, halted or even prevented if treatment starts early enough.

The Lilly drug, like most of the more than 100 Alzheimer’s drugs under development, blocks an enzyme, gamma secretase, needed to make beta amyloid. It was among the first shown to breach the blood-brain barrier and reduce levels of beta amyloid in the brain. And, company studies showed, it did reduce amyloid production.

“we did get enough in the brain to have an effect,” said Eric Siemers, medical director of Lilly’s Alzheimer’s disease team. “Unfortunately, the effect was not what we wanted.”

Now researchers are focused on what went wrong, and why.

Some, like Lon Schneider, an Alzheimer’s researcher at the University of Southern California, say the drug’s failure may mean the field is rushing off a cliff in its near single-minded focus on blocking the production of amyloid. the Lilly study’s failure, he said, “chips away at that approach to testing the amyloid hypothesis.

“we don’t know what the drug targets for Alzheimer’s disease are,” Dr. Schneider said. “we don’t know because we don’t know the causes of Alzheimer’s.”

At the very least, said Murali Doraiswamy, an Alzheimer’s researcher at Duke University, the Lilly result “clearly tells us that our current views may be too simplistic.”

Dr. Doraiswamy said he was not abandoning the amyloid hypothesis. but, he said, “this is a time of major soul-searching in the field.

“what worries me is that we don’t know if this was a toxicity unique to Lilly’s drug and this late-stage population or whether it also applies to similar anti-amyloid therapies given at earlier stages of the disease,” Dr. Doraiswamy said.

The bad news came on the heels of what researchers see as a resurgence of hope in this challenging field. with new co-operation in research they have made advances in diagnosing Alzheimer’s, a disease that used to be uncertain until autopsy.

PET scans of amyloid plaques in the brain and tests of cerebrospinal fluid can show amyloid accumulation long before people have symptoms of Alzheimer’s disease and, as recently reported, appear to identify people at high risk of developing the disease. Researchers believe the best time to try to alter the course of the disease is before memory loss. By then, brain cells are dead or dying and are unlikely to be restored.

At this point, though, when there is no treatment, those tests are primarily a benefit for companies testing new therapies and researchers trying to understand the disease’s progress. but they don’t offer immediate hope for those currently afflicted with the disease. new York Times News Service