FDA to require stricter labeling of drugs containing propoxyphene.

The Washington Post (7/8, Brown) reports, “The Food and Drug Administration said Tuesday that it will require stricter labeling of drugs containing propoxyphene,” such as Darvon, “a mild opiod painkiller that the European Union’s FDA-equivalent decided last month to phase out of use.” The drug “is sold as Darvocet” when “combined with acetaminophen.” The agency said, however, “that propoxyphene is useful enough to remain on the market, at least for now.” http://www.washingtonpost.com/wpdyn/content/article/2009/07/07/AR2009070702483.html

 

        The agency “is requiring makers to add a boxed warning…about the risk of fatal overdoses,” USA Today (7/8, Rubin) reports. In addition, drugmakers will be required “to create a medication guide for distribution to patients when the drug is dispensed,” and “conduct a new safety study to examine the effect of overdoses on users’ hearts.” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, noted that “this is an acceptable option for patients.”

http://www.usatoday.com/news/health/2009-07-07-fda-darvocet_N.htm

 

        The Wall Street Journal (7/7, Dooren) reports that the study will focus on “how often the elderly are prescribed propoxyphene products instead of other pain relievers and the differences in the safety profiles of propoxyphene compared to the other drugs.” The agency consulted “an outside panel of medical experts” earlier this year, which “narrowly suggested the agency remove the drugs from the market.” The panel stated that “the benefits…didn’t outweigh the risks.”

http://online.wsj.com/article/SB10001424052970204261704574274300825489532.html

 

        In the Los Angeles Times (7/7) Booster Shots blog, Melissa Healy noted that “propoxyphene’s dangers most recently came to light in February 2006, when the group Public Citizen petitioned the FDA to remove the drug from the market.” The group “sued the FDA in June of last year for failing to rule on its 2006 petition, prompting the FDA to act this week.”

http://latimesblogs.latimes.com/booster_shots/2009/07/fda-old-pain-pills-to-carry-new-warnings.html

        Dr. Sidney Wolfe, of Public Citizen, said, “This is a reckless decision on the part of the FDA unless they believe Americans are resistant to the death-causing properties of this drug in a way that Europeans and people in the UK aren’t,” the AP (7/8, Neergaard) reports. But, “in Web-posted information for consumers Tuesday, the FDA said the drug is used differently in Europe.” Commenting on the agency’s decision, Woodcock “stressed that other painkillers come with their own side effects.”

http://www.google.com/hostednews/ap/article/ALeqM5jK3ebBNs9gDcoPf5GPL0yTMq0eUQD999SGH85

        According to Bloomberg News (7/8, Larkin), the FDA “received 91 reports of deaths linked to the medicine from 1969 to 2005, mostly related to overdoses and suicide attempts involving a combination of medicines.”

http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aW1IWI3oYYKg

Other Pharma News

FDA accepts application for once-a-week diabetes drug.

The AP (7/8) reports, “Drugmakers Eli Lilly and Co., Amylin Pharmaceuticals Inc. and Alkermes Inc. said Tuesday the Food and Drug Administration has accepted their application for the once-a-week diabetes drug exenatide.” The drug “is intended to be injected weekly.” The product is designed “to help diabetes patients keep their blood glucose under control by sending a signal to the pancreas, leading to the production of insulin.”

http://www.forbes.com/feeds/ap/2009/07/07/ap6627525.html

White House signals it will not back drug reimportation.

The Wall Street Journal (7/8, Mundy) reports Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, said he “has heard reassuring words from White House officials about the longstanding issue of allowing reimportation of prescription drugs from other countries. Industry representatives met at the White House Tuesday with officials to consider specifics of a cost-saving agreement the industry reached last month with healthcare negotiators.” The Journal notes that as a presidential candidate, President Obama “endorsed re-importation, an idea the industry opposes,” but White House officials “have told the industry if the larger healthcare bill passes, the cost savings will be so great that reimportation will be unnecessary.” Sen. Bernie Sanders “said he disagrees with any move to drop the reimportation idea.”

http://online.wsj.com/article/SB124700977149808565.html#mod=testMod

Drug companies “nervously” anticipate EU antitrust investigation results. 

The Financial Times (7/8, Tait) reports, “Drug companies are nervously anticipating action by Europe’s antitrust regulators in the wake of a final report into the way new medicines are developed and brought to market, due to be published” Wednesday. The report “is the result of an 18-month probe by EU competition officials, is not expected to accuse individual companies of wrongdoing, and will draw only general conclusions about the way in which pharmaceutical companies and generic drug manufacturers interact with patent system.” But lawyers “expect individual investigations into suspected anti-competitive practices will inevitably follow” from the European Commission.

http://www.ft.com/cms/s/0/c9c662d8-6b57-11de-861d-00144feabdc0.html

JAMA to alter policy on disclosing possible conflicts of interest.

The Wall Street Journal (7/8, Armstrong) reports, “The Journal of the American Medical Association backed off a policy ordering public silence from anyone filing a complaint about study authors’ possible undisclosed financial conflicts until a probe is complete.” In an editorial in March, the journal that “said anyone filing a complaint about unreported conflicts of interest would ‘be specifically informed that he/she should not reveal this information to third parties or the media while the investigation is underway.'” But, in a new editorial, “the editors now say they ‘will explain to the person bringing the allegation that gaining full cooperation of all parties with knowledge of the facts is likely to be enhanced by maintaining confidentiality while the investigation is under way.” The journal’s initial policy “came after JAMA was criticized for taking five months to acknowledge that a study it published last year on the use of antidepressants in stroke patients was written by a University of Iowa psychiatrist who failed to disclose he had a financial relationship with the maker of the drug studied.”

http://online.wsj.com/article/SB124700923018308521.html 

OSI Pharmaceuticals consolidates US operations.

The AP (7/8) reports, “OSI Pharmaceuticals Inc. said Tuesday it will consolidate its US operations onto a single campus in Westchester County, NY, to save money.” The company “expects to finish the consolidation by the end of 2010, and said the move will save the company more than $15 million per year.” But the “move does not [affect] its diabetes and obesity business in Oxford, England.” http://www.forbes.com/feeds/ap/2009/07/07/ap6627626.html 

        Reuters (7/8) also reports that OSI will consolidate about 350 of its employees to the new facility in the second half of this year. The company said it agreed to buy the 43-acre site for $27 million. http://www.reuters.com/article/rbssHealthcareNews/idUSBNG46540720090707

BioScrip Commences Patient Enrollment in Teva Neuroscience Therapy Optimization in MS Research Study

ELMSFORD, N.Y.–(BUSINESS WIRE)–Jun 30, 2009 – BioScrip, Inc. announced today that Teva Neuroscience tapped BioScrip Specialty Pharmacy as one of several national research study participants in one of the most comprehensive MS research studies announced to date.

http://pharmalive.com/news/index.cfm?articleID=636896&categoryid=46 

Johnson & Johnson and Elan Corporation Announce Definitive Agreement for Alzheimer’s Immunotherapy Program and Equity Investment

NEW BRUNSWICK, N.J. and DUBLIN, July 2 /PRNewswire-FirstCall/ — Johnson & Johnson and Elan Corporation plc today announced a definitive agreement whereby Johnson & Johnson will acquire substantially all of the assets and rights of Elan related to its Alzheimer’s Immunotherapy Program (AIP Program), through a newly formed company. http://pharmalive.com/news/index.cfm?articleID=637467&categoryid=46

Following a vote by an FDA expert panel that favored banning drugs that combine drugs that combine acetaminophen with narcotics such as Vicodin and Percocet, doctors are reassuring chronic pain patients that alternative options do exist.

 20090709-5

The New York Times, July 2009, by Gardiner Harris  —  ADELPHI, Md. – A federal advisory panel voted narrowly on Tuesday to recommend a ban on Percocet and Vicodin, two of the most popular prescription painkillers in the world, because of their effects on the liver.

The two drugs combine a narcotic with acetaminophen, the ingredient found in popular over-the-counter products like Tylenol and Excedrin. High doses of acetaminophen are a leading cause of liver damage, and the panel noted that patients who take Percocet and Vicodin for long periods often need higher and higher doses to achieve the same effect.

Acetaminophen is combined with different narcotics in at least seven other prescription drugs, and all of these combination pills will be banned if the Food and Drug Administration heeds the advice of its experts. Vicodin and its generic equivalents alone are prescribed more than 100 million times a year in the United States.

Laureen Cassidy, a spokeswoman for Abbott Laboratories, which makes Vicodin, said, “The F.D.A. will make a final determination and Abbott will follow the agency’s guidance.”

The agency is not required to follow the recommendations of its advisory panels, but it usually does.

The panel’s 20-17 vote to recommend a ban on the combination drugs was one of 11 it took at a meeting called to advise the F.D.A. on problems arising from the extraordinary popularity of acetaminophen. In 2005, American consumers bought 28 billion doses of products containing the ingredient.

While the medicine is effective in treating headaches and reducing fevers, even recommended doses can cause liver damage in some people. And more than 400 people die and 42,000 are hospitalized every year in the United States from overdoses.

In hopes of reducing some of these accidents, the committee voted 24 to 13 to recommend that the F.D.A. reduce the highest allowed dose of acetaminophen in over-the-counter pills like Tylenol to 325 milligrams, from 500. And members voted 21 to 16 to reduce the maximum daily dosage to less than 4,000 milligrams.

But they voted 20 to 17 against limiting the number of pills allowed in each bottle, with members saying such a limit would probably have little effect and could hurt rural and poor patients. Bottles of 1,000 pills are often sold at discount chains.

“We have no data to show that people who overdose shop at Costco,” said Dr. Edward Covington, a panel member from the Cleveland Clinic Foundation.

Dr. Lewis S. Nelson, a toxicologist from the New York University School of Medicine who served as the panel’s acting chairman, said experts had been warning of the dangers of combination painkillers like Percocet, which is made by Endo Pharmaceuticals, and Vicodin for years.

Still, the recommendation is likely to come as a shock to many patients, who may be unaware of the dangers of high doses of acetaminophen – even if they know the drugs contain the ingredient.

Some doctors already avoid prescribing pills that combine acetaminophen with narcotics like oxycodone (found in Percocet) and hydrocodone (in Vicodin).

“It ties the doctor’s hands when you put the two drugs together,” said Dr. Scott M. Fishman, a professor of anesthesiology at the University of California, Davis, and a former president of the American Academy of Pain Medicine. “There’s no reason you can’t get the same effect by using them separately.”

Dr. Fishman said the combinations were prescribed so often for the sake of convenience, but added, “When you’re using controlled substances, you want to err on the side of safety rather than convenience.”

Still, some doctors predicted that the recommendation would put extra burdens on physicians and patients.

“More people will be suffering from pain,” said Dr. Sean Mackey, chief of pain management at Stanford University Medical School. “More people will be seeing their doctors more frequently and running up health care costs.”

In a statement, Johnson & Johnson, Tylenol’s maker, said it “strongly disagrees” with the proposed restrictions on acetaminophen, adding that they would be likely to “lead to more serious adverse events as consumers shift to other over-the-counter products,” like Advil and aspirin.

Linda A. Suydam, president of the Consumer Healthcare Products Association, said the committee had ignored studies showing that doses sold by her members – two pills of 500 milligrams, up to four times a day – were safe. “I think this is a very effective dose and one needed for individuals who experience chronic pain,” she said.

The committee also turned its attention to over-the-counter children’s medicines containing acetaminophen, voting 36 to 1 to limit them to a single formulation. Right now the liquids are sold in two different concentrations, leading to confusion among doctors and parents.

“I don’t think it’s safe to have two formulations out there,” said Dr. Nelson, the acting chairman.

The members were divided over which formula to recommend, the concentrated or the less concentrated one. F.D.A. officials suggested that they would likely settle on the less concentrated formula so that if parents make a mistake, they would be less likely to overdose.

Acetaminophen is included in a vast array of over-the-counter cough and cold products, including Nyquil, Excedrin and many others. A small share of accidental poisonings result when people take two or more of these combination products without understanding the risk.

The F.D.A. asked the committee whether it should ban combination products that include acetaminophen. The vote was 24 to 13 against such a ban, with many members saying consumers saw the products as valuable.

“Based on the data provided, the combination O.T.C. medications really contributed very little to overall poisonings,” said Dr. Osemwota A. Omoigui, a panel member from the Los Angeles Pain Clinic.

A 2005 study found that most poisonings resulted from patients’ taking Vicodin and similar products that combine a narcotic with acetaminophen.

“I think this is the one place where we can engineer in safety,” said Dr. Judith M. Kramer, a panel member and an associate professor of medicine from Duke University Medical Center who voted to ban the combination prescription medicines. “We’re here because there are inadvertent overdoses that are fatal, and this is our one opportunity to have a big impact.”

Consumers need to be better educated about the risks of popular medicines, most panel members agreed.

“If you keep track of what you’re taking, none of this is an issue for you,” Dr. Jan Engle, a panel member and head of the Department of Pharmacy Practice at the University of Illinois in Chicago, said in an interview after the meeting.

Donald G. McNeil Jr. contributed reporting from New York.

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The New York Times, July 7, 2009, by Tara Parker-Pope  —  Few drugs are more ubiquitous than acetaminophen, the pain reliever found in numerous over-the-counter cold remedies and the headache drug Tylenol.

But last week, a federal advisory committee raised concerns about liver damage that can occur with overuse of acetaminophen, and the panel even recommended that the Food and Drug Administration ban two popular prescription drugs, Vicodin and Percocet, because they contain it.

The news left many consumers confused and alarmed. Could regular use of acetaminophen for pain relief put them at risk for long-term liver damage?

To help resolve the confusion, here are some questions and answers about acetaminophen.

What prompted the committee to look at acetaminophen in the first place?

Every year about 400 people die and 42,000 are hospitalized as a result of acetaminophen poisoning. When used as directed, the drug is not hazardous. But acetaminophen is now in so many products that it is relatively easy to take more than the recommended daily limit, now four grams.

“People often don’t know what products acetaminophen is in,” said Dr. Lewis S. Nelson, a medical toxicologist from New York University who was the panel’s acting chairman. “It isn’t that hard to go above the four-gram dose. If you took a couple acetaminophen for a headache until you got to the maximum dose, and then maybe later you take Tylenol PM and some Nyquil for a cold. And your back hurts, so you take Vicodin – by now you’ve probably gotten to a seven-gram dose.”

What did the panel recommend?

Besides a ban on Percocet and Vicodin, it called on the F.D.A. to lower the total recommended daily dose of acetaminophen from the current level of four grams, which is about 12 tablets of regular strength Tylenol. The new maximum dose is likely to be 2.6 to 3.25 grams, equal to 8 to 10 regular pills.

The panel also recommended that “extra strength” doses – equal to two 500-milligram pills – be switched to prescription only, and that the largest dose available over the counter be limited to two 325-milligram pills. It also recommended that infants’ and children’s doses be standardized to prevent errors.

As a precaution, should consumers switch to other types of over-the-counter pain relief?

Emphatically, no. Every drug has risks and side effects, but over all the risk of acetaminophen to any individual is low. Far more people are harmed by regular use of aspirin and ibuprofen, which belong to a class of medicines called nonsteroidal anti-inflammatory drugs, or Nsaids. By most estimates, more than 100,000 Americans are hospitalized each year with complications associated with Nsaids. And 15,000 to 20,000 die from ulcers and internal bleeding linked to their use.

By comparison, there are only about 2,000 cases of acute liver failure, and about half of them are related to drug toxicity. Of the drug-induced cases, 40 percent are due to acetaminophen, and half of those are a result of intentional overdose.

“Nearly everybody on the panel recognizes that from a public-health perspective, ibuprofen is much more concerning than acetaminophen,” Dr. Nelson said.

For users of Percocet and Vicodin, the picture is cloudier. Hydrocodone, the narcotic in Vicodin, is not available as a single drug. Oxycodone, the narcotic in Percocet, will remain available. But these ingredients are tightly controlled, and prescriptions may require extra time and paperwork.

If I’ve been using a drug like Vicodin, should I be worried about long-term liver damage?

The risks associated with acetaminophen overdose are acute or immediate liver failure, not chronic liver disease. Even if you’ve been taking Tylenol or other drugs with acetaminophen for years, there is no reason to worry about long-term liver damage as long as you are using them as directed. (By comparison, regular use of Nsaids like aspirin and ibuprofen can lead to chronic gastrointestinal problems over time.)

An overdose of acetaminophen does not typically produce immediate symptoms. Instead, drug-induced hepatitis is likely to develop within a week, leading to loss of appetite, nausea, vomiting, fever and abdominal pain. Dark urine and jaundice (yellowing of the skin and eyes) suggest a more serious case. Usually the liver will recover once the drug is stopped or with medical treatment, but many patients in acute liver failure will die without a transplant.

About 15 percent of liver transplants result from drug poisoning. In one study, 40 percent of drug-related liver transplants were due to acetaminophen, 8 percent to tuberculosis drugs, 7 percent to epilepsy treatment and 6 percent to antibiotics.

What’s the main lesson from the panel review of acetaminophen?

Because acetaminophen is in so many products, consumers need to be vigilant about reading labels, and they need to keep track of how much of the drug they are ingesting daily.

“It would be a real shame if people in reading these stories got the idea that acetaminophen is not safe,” said Dr. Paul Watkins, director of the Institute for Drug Safety Sciences at the Hamner Institutes and the University of North Carolina. “It’s totally safe when taken as directed. The problem is that people end up unknowingly taking much more than recommended.”

Harvard Medical School, July 7, 2009  —  It isn’t always easy to distinguish someone having a heart attack from someone with a bad case of indigestion or a strained chest muscle. Out of every 100 people who are having a heart attack, between two and eight are mistakenly told they’re “fine” and sent home, suggest The New England Journal of Medicine and other journals. 

But a new definition for heart attack from the American Heart Association, American College of Cardiology, World Heart Federation, and others should help cut down the number of missed heart attacks and make it easier to tell an attack from other conditions that can mimic one.                      

According to the new definition, the term myocardial infarction-heart attack, in doctor-speak-applies when there is evidence of heart-cell death due to insufficient blood flow.

Key ways to determine this include the following:

  • detection of a very high level of troponin, a protein found in heart cells
  • symptoms consistent with a heart attack
  • changes on an electrocardiogram that suggest insufficient blood flow to part of the heart. 

According to the new definition, you are having a myocardial infarction if a blood test shows extremely high levels of troponin or a similar biomarker plus one or both of the following: symptoms of a heart attack or changes characteristic of one on an electrocardiogram or other imaging test. 

Troponin is such a tell-tale sign of dying heart cells that expanding its use in hospitals and emergency departments could boost by 25% the number of people diagnosed each year with heart attacks. More will get the treatments they need and, at least in theory, will have better long-term survival and less disability. It also means that when a heart attack is ruled out, you and your doctor can be more confident that the decision was the right one.

For more information on preventing, diagnosing, and treating heart disease, order our Special Health Report, The Healthy Heart, at

www.health.harvard.edu/HH

20090709-3

“Four times a mouse” by Jacques de Gheyn
Image: Wikimedia

The-Scientist.com, July 9, 2009, by Bob Grant  —  A drug used to prevent the rejection of transplanted organs and as an experimental cancer treatment in humans can significantly increase lifespan when given to adult mice, researchers have found. Mice that were administered the immunosuppressant rapamycin lived an average of 9-14% longer than mice that were not fed the drug, according to a paper published online in Nature yesterday (July 8th).

“This is pretty remarkable,” Panjak Kapahi, a geneticist at the Buck Institute for Age Research in California told The Scientist. “There might be more to gain in understanding the downstream effects, but this is already a wonderful start.” Kapahi, who was not involved with the study, added that, though preliminary, the finding opens the door for further research into the drug’s use for an anti-aging intervention in humans. “It should be applicable to humans, I think.”

David Harrison, a gerontologist at The Jackson Laboratory in Bar Harbor Maine and lead author on the paper, told The Scientist that 9%, though seemingly a modest life span increase, is significant when compared to the effect of eradicating some of the most common age-related diseases in humans. “If you prevented all deaths from cancer and atherosclerosis,” Harrison said, “it would be a little less than that.”

Rapamycin works by inhibiting the target of rapamycin (TOR) signaling pathway, which plays a role in the translating mRNA into proteins and inhibits processes that degrade cellular waste. The drug has been found to extend the life spans of yeast, fruit flies, and nematodes. “This is really the first demonstration that inhibiting TOR also increases lifespan in mammals,” said Matt Kaeberlein, a pathologist at the University of Washington in Seattle who was not involved with the study.

Kapahi, who discovered in 2004 that the TOR pathway played a role in extending the life spans of fruit flies, said that Harrison’s study is both a “great victory for the invertebrate models of aging,” and a fruitful way forward to investigate a potential anti-aging treatment in humans. “You would put your money on a pathway that you know has worked in four different organisms,” he said. “This is as good as it gets.”

As rapamycin has previously been shown to increase the life spans of invertebrate model organisms, its effect in mice is not entirely surprising, according to Kaeberlein, who wrote a commentary that accompanies the Nature paper. More surprising is the fact that the longer-lived mice in the study were not given rapamycin until they were 600 days old. “That is very surprising to myself and to a lot of people,” Kaeberlein told The Scientist. “And it’s a very important result.” A 600-day-old mouse is roughly equivalent to a human that is 60 years of age, and other successful anti-aging interventions have not proved effective so late in an organism’s life.

Kaeberlein said that rapamycin’s effectiveness in middle aged mice represents an interesting therapeutic opportunity in humans, because “almost everything that has been found to significantly increase lifespan in model organisms leads to some sort of fitness costs” — usually by stunting growth or reducing reproductive capacity. A rapamycin-based anti-aging pill administered later in life might circumvent these problems.

Harrison agreed. “It’s certainly possible that there may be optimal times to start things when you’re old that might be deleterious when you’re young,” he said. But he joined Kaeberlein and Kapahi in cautioning that the findings should not be interpreted as an invitation for age-conscious humans to ingest the drug. “It’s not time to start popping rapamycin for anti-aging,” Harrison said, adding that taking rapamycin likely carries significant risks common to other immune suppressants or immunocompromising diseases.

Several questions surrounding the results and rapamycin’s impact on the TOR pathway and aging remain to be answered. “What’s happening in these animals that are given rapamycin and are living a long time?” asked Kaeberlein. “That’s going to be important for the next set of experiments to look at.”

Harrison said that he and other researchers collaborating in the National Institute on Aging’s Interventions Testing Program are examining the drug’s cellular effects and testing a suit of other compounds suspected to increase the longevity of mammals. The effect of rapamycin and the indication that the TOR pathway is important in mammalian aging is a major step towards developing a drug that might prolong human life, he said. “I think this makes us a lot closer than we were before,” he said. “Who knows what’s going to work, but we have a point here that’s ever so much more specific and interesting than we had to start with.”

Reviewed by Brunilda Nazario, MD 

WebMD.com, July 7, 2009, by R. Morgan Griffin  —  Soy protein can be a meal, a side dish, a snack, or a drink. Made from the soybean, it’s a staple of Asian diets. Yet it’s largely been the butt of jokes about hippies and vegans — until recently. Today, the buzz about soy is serious. Can it lower cholesterol naturally? Some studies say yes. But, unfortunately, research shows mixed results. We may not know the answer for years.

How Might Soy Protein Help?

A number of studies over the past decade seemed to show soy protein could lower “bad” LDL cholesterol and triglycerides without lowering “good” HDL cholesterol. Researchers aren’t exactly sure how soy protein might help. It could be a combination of the effect of the protein and natural chemicals in soy called isoflavones. The American Heart Association has announced that a review of 22 clinical studies concluded that eating soy-based foods has only minimal impact on cholesterol and other heart-disease risk factors.

Until further research clears up the controversy, should you dump soy from your diet? Not at all, says Tufts University nutrition researcher Alice Lichtenstein, DSc, who helped write the AHA statement. “Soy is a great food. It is low in saturated fat and it is a good-quality protein,” she says — even if its heart benefits are less than expected.

Conflicting Evidence on Soy

There have been many studies of the effects of soy on cholesterol. One major article published in The New England Journal of Medicine found that replacing animal protein with soy protein could lower levels of total cholesterol, bad LDL cholesterol, and triglycerides. At the same time, it didn’t significantly lower levels of “good” HDL cholesterol.

Some studies have shown that soy protein, when eaten along with other cholesterol-lowering foods, can have a big effect. In a study published in the American Journal of Clinical Nutrition in 2005, researchers tested cholesterol-lowering drugs against cholesterol-lowering foods in a group of 34 adults with high cholesterol. People ate 50 grams of soy protein daily along with other cholesterol-lowering foods. The results were striking: the diet lowered cholesterol levels about as well as cholesterol drugs.

However, not all studies agree. An analysis of various studies led by the U.S. Agency for Healthcare Research and Quality found that soy had a modest effect on cholesterol levels. Researchers found that eating a high amount of soy — equal to about a pound of tofu a day — only added up to a 3% reduction in “bad” cholesterol levels.

Based on those more recent studies, the AHA Nutrition Committee no longer recommends eating soy specifically to lower cholesterol. However, the AHA does consider soy burgers and other soy foods a healthy replacement for high-fat meats.

There are almost endless ways of getting soy into your meal plan. Here’s a rundown of some of your options.

  • Tofu is a solid extract of soybeans. “It has a mild, bean-like flavor,” says Ruth Frechman, RD, a spokeswoman for the American Dietetic Association (ADA.) “It can be added to anything you cook or it can be eaten right out of the package.” Tofu is often used in stir-fries, curries, or stews. It tends to pick up the flavor of the sauce it’s in.
  • Soy nuts are roasted soybeans, which can make a tasty snack. “Soy nuts are a convenient, crunchy source of protein,” Frechman tells WebMD.
  • Soymilk is made from ground soybeans mixed with water. You can substitute soymilk for milk in your coffee or your cereal. Or you can just drink it on its own. “A lot of my clients really like smoothies made with soy milk,” says ADA spokeswoman Suzanne Farrell, MS, RD. “That’s a great way to get soy into your diet.”
  • Soy burgers, soy cheese, and other products now fill the freezers and refrigerators at your local supermarket. Manufacturers have come up with soy products that mimic just about every kind of meat and dairy product. Buy a few different types and give them a try.
  • Edamame are soybeans still in the pod. They’re sold either frozen or fresh. Frechman recommends microwaving frozen edamame in a little water and chicken bouillon for an easy way to get soy protein.
  • Tempeh is a fermented soybean cake. It can be used as a meat substitute, and works well in spaghetti sauce.
  • Miso is a paste made from soybeans that is used for soup stocks or as a seasoning.
  • Soy flour is a powder made from ground, roasted soybeans. It can be added to baked goods.

Choose the foods that you like. The key is to substitute soy for high-fat meats, such as hamburger. 

We don’t presume to recommend any products for anyone; however, two people at Target Health Inc. appear to have lowered their cholesterol, after taking one 600 mg red rice yeast tablet, each evening, over a period of 4 months.  Check with your doctor, before trying anything to lower your cholesterol.

Abstract

GoogleNews.com, Nature.com, July 6, 2009  —  Recent years have seen increased interest in and funding for initiatives that aim to bridge the ‘translational gap’ between basic and clinical research. Two interviewees this month discuss the discipline from different vantage points.

Garret A. FitzGerald, M.D. Chair, Department of Pharmacology and Director, the Institute for Translational Medicine and Therapeutics, University of Pennsylvania, Philadelphia, USA.

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Garret A. FitzGerald, M.D. Chair, Department of Pharmacology and Director, the Institute for Translational Medicine and Therapeutics, University of Pennsylvania, Philadelphia, USA.

In order to cluster and expand resources that are relevant to translational research, the University of Pennsylvania (Penn) launched the Institute of Translational Medicine and Therapeutics (ITMAT) in January 2005. Previously, these resources were “…dispersed and largely invisible to trainees and faculty as an integrated entity…” says Garret FitzGerald, Director of ITMAT. Now, the Institute includes 650 investigators focused on clinical and translational research in all schools at Penn, the Children’s Hospital of Philadelphia, the Wistar Institute and the University of Sciences in Philadelphia. In addition, ITMAT has been awarded a Clinical and Translational Science Award by the National Institutes of Health.

From the early stages of his career, FitzGerald has been interested in both clinical medicine and basic pharmacology. Following his medical degree at University College Dublin (UCD) in 1974, he completed an internship and residency at teaching hospitals in Dublin that shaped the course of his future. “As an intern I was fortunate to see Colin Dollery speak at a symposium on the nascent discipline of clinical pharmacology,” says FitzGerald. “His vision and eloquent exposition of its importance captured my imagination.”

Inspired by Dollery, FitzGerald applied for, and was awarded, a fellowship by the Wellcome Trust that he completed at Hammersmith Hospital in London. During this time, he met John Oates, Professor of Medicine and Pharmacology at Vanderbilt University Medical Center in Nashville, Tennessee. Like Dollery, Oates impressed him with his science and vision and – after another fellowship funded by the Alexander von Humboldt Foundation that allowed FitzGerald to go to the Max Planck Institute and the Department of Cardiology at the University of Cologne – FitzGerald moved to Vanderbilt University, where he eventually led the division of Clinical Pharmacology. “All along, I have been very fortunate to be mentored by people who saw the value of integrating basic science with clinical medicine,” he says.

After 11 years at Vanderbilt University, FitzGerald returned to Dublin in 1991 as Chair in Medicine at UCD. Over the following few years, he founded a centre for cardiovascular science; however, he was attracted back to the USA in 1994. “I was very impressed by William Kelley, the then Dean at Penn. He had a clear expectation of success but was prepared to invest realistically in a novel programme,” he says.

Although FitzGerald’s interest in translational medicine has guided his 35-year career, in parallel the number of physician scientists has declined, even though their work has catalysed the growth and achievement of biomedicine. “Sadly, our academic medical centres have increasingly been dominated by the demands of clinical revenue generation,” says FitzGerald. “Very few people can project their basic science into mechanistic studies in humans.”

Institutes such as ITMAT are essential to address this challenge. “We have to educate a new breed of individuals who can integrate the skill sets, and to do that we need a brand name – perhaps ‘Translational Medicine and Therapeutics’ – and to advertise it so that it is attractive to our best trainees,” he says.

Bruce H. Littman, M.D. President, Translational Medicine Associates, LLC, Stonington, Connecticut, USA.

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Bruce H. Littman, M.D. President, Translational Medicine Associates, LLC, Stonington, Connecticut, USA.

After retiring as Vice President of Global Translational Medicine at Pfizer at the end of 2007, Bruce Littman started a consulting business to assist clients – such as small biotechnology and pharmaceutical companies, non-profit research organizations and venture capitalists – in areas related to translational clinical research and personalized medicine. “I also work with colleagues across most therapeutic areas including drug safety, medicinal chemistry, discovery biology and late-stage clinical development,” says Littman.

His interest in translational clinical research began in 1970 at the University of Buffalo’s medical school, part of the State University of New York, where he spent time as a student working in immunology laboratories. Between an internship and residency at Tuft’s New England Medical Center in Boston, USA, he worked at the National Institutes of Health’sNational Cancer Institute, applying his immunology expertise to tumour immunology. This led on to a research fellowship at Harvard with John David, co-discoverer of the first cytokine, migration inhibitory factor (MIF), and to his decision to specialize in rheumatology and clinical immunology.

He then moved to Virginia Commonwealth University (VCU), progressing from assistant to full professor over 13 years, during which time he became interested in working for industry. “I felt that my research was going well, but it would not impact the lives of rheumatoid arthritis patients for decades, if at all,” he says. “I learned that Pfizer was about to start a new group called Experimental Medicine, and the translational role of this group was both exciting and groundbreaking in the industry. I made the move and never looked back.”

After 19 years at Pfizer, he became convinced that current strategies for drug discovery and development need to become more focused on molecularly defined patient populations. “I felt that large pharma was becoming less innovative and more focused on maintaining a pipeline of commercially successful products,” he says.

Littman therefore decided to become an independent consultant. “This has allowed me to advocate scientifically driven development strategies for new drugs and diagnostics and to develop personalized medicine paradigms for both marketed and new medicines.” In addition, he is Co-Chair of The Immunity and Inflammation Steering Committee of The Biomarker Consortium, a public-private partnership run by the Foundation for the National Institutes of Health.

Now, the range of translational research projects that he is involved in helps to keep him abreast of relevant challenges. “Sometimes the issues provoke lots of thought about alternative models, not only for drug discovery and development, but also for much broader areas such as health-care delivery, cost-effectiveness and implementation of personalized medicine,” he says.

For anyone embarking on a translational research strategy, he has this advice: “No matter how solid and forward-thinking your research strategy is, the result is dependent on the quality of your techniques and biomarker technologies. Rigorously qualify these before attempting to implement them for decision-making research.”

Translational Medicine is an emerging view of medical practice and interventional epidemiology, as a natural 21st century progression from Evidence-Based Medicine. It integrates research inputs from the basic sciences, social sciences and political sciences to optimize both patient care and also preventive measures which may extend beyond the provision of healthcare services.

Translational research

Translational Research is the underlying basis for Translational Medicine ‘the process which leads from evidence based medicine to sustainable solutions for public health problems.  Fulfilling the promise of translational research for improving the health and longevity of the world’s populations depends on developing broad-based teams of scientists and scholars who are able to focus their efforts to link basic scientific discoveries with the arena of clinical investigation, and translating the results of clinical trials into changes in clinical practice, informed by evidence from the social and political sciences.* It has three phases.

Phase 1 Translational Research is the research process that explores needs, develops potential treatments in basic laboratory research, and tests safety and efficacy, principally in randomized clinical trials. The concept arose from research into pharmacotherapy and formed the initial basis for evidence-based practice and clinical guidelines, now incorporated into Translational Medicine. In the case of drug discovery and development, translational research typically refers to the translation of laboratory-based research into real therapies for real patients. This is often called the “bench to bedside” definition. Many pharmaceutical companies are building (phase 1) translational medicine groups to facilitate the interaction between basic research and clinical medicine, particularly in clinical trials. The clinical evaluation of therapies drawn from other disciplines (eg psychology, physical activity, nutritional) can also be included within Phase 1 Translational Research.

Phase 2 Translational Research examines how findings from clinical science, shown to be efficacious and safe treatments established in phase 1 translational research, function when they are applied in routine practice, as first described by Hiss RG.   It thus addresses development and application of new technologies in a patient driven environment – where the emphasis is on real patients in real-life situations, where demographic factors and competing priorities modify clinical decisions, and treatment responses. Phase 2 Translational Research thus informs guidelines about needs, acceptability, effectiveness, and cost efficiency in ecological settings and policies to promote uptake for optimal management and resource use. As examples, consumer research explores patients’ behavioral responses to interventions and provides important insights into compliance; health economics adds the evaluation of cost effectiveness and cost avoidance. These needs challenge hierarchical views of “research quality” and funding allocation, traditionally dominated by randomized controlled trials, and point to the need for non-hierarchical typological approaches.

Phase 3 Translational Research adds the necessary information to convert treatments and prevention strategies, shown to be effective and cost-effective in Phase 2 Translational Research, into sustainable solution.  Thus governments can generate enduring evidence-based policies. These require different types of research processes to evaluate the complex interacting environmental and policy measures that affect susceptibility to disease and the sustainability of clinical and public health management and prevention strategies. Achieving sustainability depends on evidence from two fronts. Firstly, closed-loop audit approaches are needed within Continuous Improvement Methodology to refine the intervention. Lessons can be learned from successful commercial and product developments, which use multidisciplinary non-experimental research to inform incremental improvements.  Continuous improvement methodology is known as “kaizen” in Japanese, where it originated. Secondly, research is needed to obtain evidence for making changes to multiple environmental and policy factors which will reduce the need for funding to sustain the intervention.

An example – Obesity

Controlling the mounting prevalence of obesity and its secondary diseases will require new multicomponent methods for effective treatments, based on randomized clinical trials and continuous improvements of community-based approaches, and also effective and sustainable approaches for prevention. This needs an integrated view of educational and environmental actions to facilitate greater physical activity, together with fiscal and regulatory changes to promote production, promotion, and delivery of healthier meals and total food supply. Practitioners, policy makers, and the public need sound evidence from different and new research methods, involving both experimental and non-experimental methodologies, that are sensitive to cultural and ethnic priorities.

Implications of translational medicine

Reliance on actions within health services will be insufficient to control rising obesity, diabetes, and associated diseases. Clinical science and ecological support from effective policies cannot continue to be regarded as independent disciplines. Integrated training in translational research methods is needed for clinicians, guideline writers, grant awarding bodies, and policy makers, in order to redress current biases in funding and research publications, in order to reflect better the balance of research efforts which are necessary for better assessment of complex evidence-bases, to integrate effective and culturally sensitive interventions with supporting environmental changes, and to encourage continuous improvement of evidence based public policies.