Hiv Vaccine Success May Take Decade to Unravel Why It Works
A study of 16,000 volunteers in Thailand, reported last week, found those getting the immunization had a 31 percent lower infection rate than those given a placebo, the first time any vaccine had positive results. The report startled scientists, many of whom had dismissed the trial as a dead end, said Anthony Fauci, director of the National Institute of Allergy and Infectious Disease in Bethesda, Maryland.
The injection must be at least 50 percent effective before widespread immunization is feasible, said Josh Ruxin, director of the Access Project program in Rwanda. Researchers led by Fauci say they cant improve the vaccine until they understand how it blocked infections, or why it failed to show any benefit for people who still got infected with HIV.
“Some of our preconceived notions about what to measure and what we think is important might have just been turned on its head,” said Colonel Nelson L. Michael, director of the division of retrovirology at the Walter Reed military hospital in Washington, in a news conference. The U.S. military helped conduct the trial.
HIV infects about 7,400 new people every day worldwide, and led to 2 million deaths in 2007 according to UNAIDS. While there are treatments that can suppress the virus for those who can afford them, there is no cure. Even after the success of the vaccine study, a much-needed vaccine may yet be 10 years away, according to the Access Projects Ruxin and Jeffrey Kraws, chief executive officer of Crystal Research Associates in New York.
Two Vaccines
The Thai study combined two vaccines, neither proven. One was ALVAC, developed by Sanofi-Aventis SA in Paris. The other was AIDSVAX, created by a Genentech Inc. spinoff, VaxGen Inc. AIDSVAX was later licensed to Global Solutions for Infectious Diseases, a nonprofit group led by Donald Francis, who left VaxGen in 2003 after initial trials failed.
AIDSVAX, which failed in previous tests, contains an HIV protein called gp120 thats designed to encourage the body to produce neutralizing antibodies to recognize and destroy HIV before it can infect healthy cells. ALVAC focuses on increasing cellular responses to attack the virus. The theory behind the combination was that ALVAC would “prime” the immune system to respond, and AIDSVAX would “boost” the antibody response.
Measurable Signs
The unexpected success “tells us that we dont even know what the correlates of immunity are,” Fauci said, referring to the measurable signs that a person has developed defenses against a virus. “But it does give us now a bit more direction for trying to track down what it is this vaccine did that led to this modest degree of protection.”
Antibodies, protective proteins developed in the body in response to a virus or vaccine, are the most common signal of immunity. Researchers havent identified neutralizing antibodies produced by the experimental vaccine, and previous quests to induce such antibodies have ended in failure, Fauci said. Scientists are also searching for signs of boosted cellular defenses that might be key to the vaccines success.
“Were not even close to being finished,” Fauci said.
Virus Levels
In the Thai trial, vaccinated patients who still contracted HIV had the same levels of virus in their blood as patients who never received the vaccine. That was perplexing, as researchers assumed it would be easier to reduce the so-called viral load than to prevent infection, said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition in New York.
Collaborators on the Thai study are continuing to track the vaccinated patients who were infected in a study called RV152 to see whether the virus levels diverge and whether symptoms are lessened. There are limited supplies of the shots, though, and it will take time to produce enough for more tests, said Donald Francis, of Global Solutions for Infectious Diseases, at the news conference announcing the finding last week.
“The samples and specimens collected from this trial have become a precious resource,” Warren said in a telephone interview. “Over the next few months well see some consensus as to what are the elements of trials that need to be conducted with the current samples.”
No Natural Immunity
After people are infected with HIV, treatment with antiviral drugs can keep HIV at bay for years, allowing patients to have healthy and productive lives, said Michel Kazatchkine, executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria. However, the virus cant be driven from the body, so patients cant develop natural immunity for doctors to use as a model for vaccine research.
“You start from nowhere,” Kazatchkine said in an interview. “Is it one of the components? Is it the mixture? Is it the way it was administered? We need to build more science, more pilot trials, and then one day, another big trial.”
Intense Tracking For Swine Flu Shots Side Effects
The government is starting an unprecedented system to track possible side effects as mass flu vaccinations begin next month. The idea is to detect any rare but real problems quickly, and explain the inevitable coincidences that are sure to cause some false alarms.
“Every day, bad things happen to people. When you vaccinate a lot of people in a short period of time, some of those things are going to happen to some people by chance alone,” said Dr. Daniel Salmon, a vaccine safety specialist at the Department of Health and Human Services.
Health authorities hope to vaccinate well over half the population in just a few months against swine flu, which doctors call the 2009 H1N1 strain. That would be a feat. No more than 100 million Americans usually get vaccinated against regular winter flu, and never in such a short period.
How many will race for the vaccine depends partly on confidence in its safety. The last mass inoculations against a different swine flu, in 1976, were marred by reports of a rare paralyzing condition, Guillain-Barre syndrome.
“The recurring question is, How do we know its safe?” said Dr. Gregory Poland of the Mayo Clinic.
Enter the intense new monitoring. On top of routine vaccine tracking, there are these government-sponsored projects:
-Harvard Medical School scientists are linking large insurance databases that cover up to 50 million people with vaccination registries around the country for real-time checks of whether people see a doctor in the weeks after a flu shot and why. The huge numbers make it possible to quickly compare rates of complaints among the vaccinated and unvaccinated, said the project leader, Dr. Richard Platt, Harvards population medicine chief.
-Johns Hopkins University will direct e-mails to at least 100,000 vaccine recipients to track how theyre feeling, including the smaller complaints that wouldnt prompt a doctor visit. If anything seems connected, researchers can call to follow up with detailed questions.
-The Centers for Disease Control and Prevention is preparing take-home cards that tell vaccine recipients how to report any suspected side effects to the nations Vaccine Adverse Event Reporting system.
“We dont have any reason to expect any unusual problems with this vaccine,” said Dr. Neal Halsey, director of Hopkins Institute for Vaccine Safety, who is directing the e-mail surveillance.
After all, the new H1N1 vaccine is a mere recipe change from the regular winter flu shot thats been used for decades in hundreds of millions of people without serious problems. Nor have there been any red flags in the few thousand people given test doses in studies to determine the right H1N1 dose. Theyve gotten the same sore arms and occasional headache or fever thats par for a winter flu shot.
But because this H1N1 flu targets the young more than the old, this may be the year that unprecedented numbers of children and pregnant women are vaccinated.
So the CDC is racing to compile a list of whats normal: 25,000 heart attacks every week; 14,000 to 19,000 miscarriages every week; 300 severe allergic reactions called anaphylaxis every week.
Any spike would mean fast checking to see if the vaccine really seems to increase risk and by how much, so health officials could issue appropriate warnings.
Very rare side effects by definition could come to light only after large-scale inoculations begin – making this the year scientists may finally learn if flu vaccine truly is linked to Guillain-Barre, an often reversible but sometimes fatal paralysis. Its believed to strike between 1 and 2 of every 100,000 people. It often occurs right after another infection, such as food poisoning or even influenza.
But the vaccine concern stems from 1976, when 500 cases were reported among the 45 million people vaccinated against that years swine flu. Scientists never could prove if the vaccine really caused the extra risk. The CDC maintains that if the regular winter flu vaccine is related, the risk is no more than a single case per million vaccinated.
So the question becomes, Is the risk of disease greater than that?
Merck Paying More Than 3,100 Fatality Claims In Vioxx Settlement
The fund will pay about 3,000 claims for heart attack deaths and at least 122 strokes, according to BrownGreer LLP, a claims administrator appointed by both sides. Merck introduced Vioxx in 1999 and withdrew it in 2004 when a study showed the drug doubled the risk of heart attacks and strokes. Merck set up the fund, which covers claims of death and lesser injuries, in 2007 after reserving $1.9 billion to fight 26,600 Vioxx suits.
“We dont know any drug right now with this number of deaths associated with it,” said Houston attorney Mark Lanier, a Vioxx plaintiffs lawyer who is appealing the reversal of a $256 million verdict against Merck. “This is a very sad chapter in the American tragedy of pharmaceutical companies gone wild.”
Merck, which is set to buy rival Schering-Plough Corp. by the end of the year, won 11 of 16 Vioxx suits at trial before agreeing to settle all claims. Under the accord, the facts of each case determine the extent of Mercks liability, which analysts once estimated to be as much as $20 billion overall. BrownGreer said its almost done reviewing 48,507 claims. So far, the firm has rejected 40 percent of them.
Stock Increase
Merck rose 24 cents to $31.25 in New York Stock Exchange composite trading yesterday, after rising as much as 2.3 percent.
“Its a good thing to clear the deck before you merge with Schering. You want to clear off all these outstanding issues so you can merge in peace. Its one less distraction,” said Les Funtleyder, a health-care analyst with Miller Tabak & Co. in New York, in a phone interview.
Families of heart attack victims who died will get an average payment of about $374,000, according to BrownGreer. Some will get as little as $5,000 and others more than $1.5 million, depending on the Vioxx users age, how long they took the drug and whether they had health risks such as obesity or hypertension, said Andy Birchfield, a plaintiffs lawyer in Montgomery, Alabama, who helped negotiate the settlement.
“The settlement relies on objective criteria,” said Merck attorney Ted Mayer of Hughes Hubbard & Reed LLP in New York. “Theres no admission regarding causation or fault. The track record in the courtroom is that plaintiffs failed again and again to establish causation.”
Lawyers Share
Claimants taking part in the settlement dont have to prove Vioxx caused their specific injuries. Details on the payments to individual claimants, who are ranked on one of six levels, are confidential. Claimants lawyers will be paid as much as $1.55 billion of the settlement fund.
Orran Brown, chairman of BrownGreer, said the fund will pay “an unspecified number” of claims on behalf of Vioxx users whose deaths didnt meet the criteria for payments related to the drugs use. He said the number hasnt been disclosed publicly and he wasnt authorized by Merck and plaintiffs lawyers to release it.
Its Plenty Bad
David Logan, dean of Roger Williams University Law School in Rhode Island, said after being told the figure, that “its plenty bad that the numbers are that high.”
Merck, based in Whitehouse Station, New Jersey, settled after battling plaintiffs who claimed in state and federal courts that it didnt adequately disclose Vioxx safety data to the U.S. Food and Drug Administration, didnt properly warn doctors and patients of the drugs risks and misrepresented the potential harm in marketing materials.
Plaintiffs claimed Merck should have moved more quickly to warn about the dangers of Vioxx after a 2000 study reported that the medicine caused five times more heart attacks than another painkiller, naproxen. Merck took two years to negotiate a change in Vioxxs label on side effects with the FDA.
“Merck acted responsibly in studying the medicine and sharing data with the FDA and physicians and in voluntarily withdrawing Vioxx from the marketplace in 2004,” Merck lawyer Mayer said.
Heart Attacks
Jerome Avorn, a Harvard Medical School professor, said “clearly there were preventable heart attacks and strokes.”
Device Approval Exposes Political Pressure On Fda
In a sweeping critique Thursday, FDA leadership said the agency failed to protect its scientists from outside pressure after they twice rejected ReGen Biologics Menaflex device.
The Hackensack, N.J.-based company ultimately won approval last December after enlisting the support of four New Jersey lawmakers, who urged then-FDA Commissioner Andrew von Eschenbach to intervene on the companys behalf.
Approval came despite protests by FDA scientists that Menaflex – which reinforces damaged knee tissue – provided little, if any, benefit to patients.
The report marks the first time FDA has openly criticized its own conduct, as Obama appointees try to restore the agencys credibility following a string of bungled drug and food safety issues.
An FDA official called the pressure from Capitol Hill “the most extreme he had ever seen” and the access granted to the commissioner “unprecedented.” Several staffers at the agency called the ReGen ordeal “the worst experience in their professional careers,” according to the report.
ReGen Chief Executive Gerald Bisbee said in a statement Thursday that FDAs review involved “procedural irregularities” and does not reflect on the safety of the companys device.
The New Jersey Democrats – Reps. Frank Pallone and Steve Rothman and Sens. Robert Menendez and Frank Lautenberg – received a combined $26,000 in campaign contributions from ReGen executives, according to OpenSecrets.org, which tracks political spending.
Rothman, who represents Hackensack, said he asked the FDA “to treat ReGen fairly, communicate with them better and to render a decision based solely on the science.”
A spokesman for Lautenberg said he simply signed a 2007 letter to the FDA along with Rothman, Menendez and former Rep. Mike Ferguson, R-N.J., who left the House in early 2009.
Spokesmen for Pallone and Menendez said the lawmakers called the FDA on ReGens behalf.
WBB Securities analyst Steve Brozak said there are probably other examples of FDA decisions influenced by politics, but since the agency controls the paper trail, they probably wont come to light.
“I would like to think this was an extreme example, but the better part of me knows it was not,” said Brozak, who covers the drug and device industries. “To think FDA isnt influenced by political activism is to not understand the system.”
“The question is how does the regulator react to the letter,” said Loss, who has covered the FDA for over 30 years at Washington Analysis, an investment firm. “In this instance, Dr. Von Eschenbach got very interested.”
After lawmakers began contacting the FDA on ReGens behalf, von Eschenbach became unusually involved in the review of Menaflex, according to the probe. Typically such matters are handled by the agencys lower-level scientific staff.
According to the report, von Eschenbach agreed to a 90-minute meeting with company executives, some of whom “appeared to want the commissioner to personally review” the device.
After the meeting, however, von Eschenbach instructed staffers to “follow the science” in issuing a decision.
A spokesman for von Eschenbach said Friday that he is not commenting on the FDA report.
Eu Drug Agency: License 2 Swine Flu Vaccines
The European Medicines Agency called for the vaccines made by Novartis AG and GlaxoSmithKline PLC to be granted a marketing authorization. The agency issues advice on whether to license for medicines across Europe, and their decisions are generally accepted by the European Commission and individual countries.
The decision to recommend the vaccines be licensed was made earlier than usual, because tests for both vaccines are ongoing. But authorities wanted to ensure the vaccines would be available before the usual flu season, when a spike in swine flu is expected.
Despite early data showing that one dose of both swine flu vaccines might work in most adults, the European Medicines Agency is recommending a two-dose regimen. Authorities expect further data from ongoing studies and said these recommendations might be updated later.
Other swine flu vaccines are being made by Sanofi-Aventis SA and Baxter International, but have not yet been approved by European authorities.
Novartis Focetria and GlaxoSmithKlines Pandemrix vaccines both use adjuvants, chemical compounds used to boost the immune system and stretch the vaccines active ingredient. The adjuvant used by Novartis has been used in flu vaccines since 1997 in more than 45 million doses, while GlaxoSmithKlines adjuvant has only been tested in clinical trials involving several thousand people.
The European Medicines Agency also said pregnant women and children older than six months should get two doses. There is limited information on how safe vaccines with adjuvants are in both these groups, thought to be particularly vulnerable in a pandemic. Some countries, such as Canada, are buying vaccines without adjuvants for pregnant women.
Novartis said it had already begun shipping the first batches of swine flu vaccine to countries across Europe. It also expects its swine flu vaccine for the U.S., which does not contain an adjuvant, to be shipped to the U.S. by early October.
Glaxo had not yet begun shipping its vaccine. Dozens of countries worldwide have placed orders with the company for 291 million doses. Glaxo shares were up 0.2 percent in late-morning trading on the London stock exchange.
Many European countries, including Britain, Denmark, France, Spain and Italy, have planned massive swine flu immunization campaigns for the fall.
In a news conference Thursday, the World Health Organization predicted drug makers could produce 3 billion pandemic doses a year. Most of that will go to rich countries who have pre-ordered the vaccine, though nine countries have offered to donate 10 percent of their supplies for the developing world.
This week, China became the first country to begin using the swine flu vaccine: about 44,000 people have so far been vaccinated. WHO said they had received reports of 14 side effects possibly linked to the Chinese-made vaccine, including headaches and dizziness.
WHO officials said any rare and potentially dangerous side effects would likely not be spotted until millions of people start getting swine flu shots.
Glaxo Search For Acquisitions Hampered By Desperate Competitors
Glaxo has done about a dozen acquisitions or development partnerships since Chief Executive Officer Andrew Witty took over in May 2008 in an effort to replace revenue that will be lost to rival generic treatments. The London-based company would do more of these deals except that prices have been driven up, said Moncef Slaoui, Glaxos head of research.
“Some of our competitors are desperate because they pay just an incredible price for some medicines,” Slaoui said in a telephone interview. “And if its a matter of life or death for them, then maybe it makes sense for them, but not to us. So sometimes we may lose some partnerships for financial reasons, which is frustrating.”
Slaoui did say that Glaxo will announce next month a move into drugs for rare diseases. He declined to name diseases that the company will target. So-called orphan medicines currently exist to treat illnesses including the genetic disorder Gaucher disease.
His comments about acquiring new treatments and building an orphan-drug business underscore the pressure facing drugmakers, which arent developing products fast enough to offset the revenue theyre losing to lower-priced copies. Drugs generating $187 billion in sales are threatened by generics between 2011 and 2014 as patents expire, according to EvaluatePharma, a London-based consulting firm.
Approval Target
Glaxo shares have fallen 6.1 percent this year, giving the company a market value of 62.6 billion pounds ($92 billion). The Bloomberg Europe Pharmaceutical Index is up 2 percent.
The drugmaker aims to double the number of treatments approved by regulators between 2006 and 2015 by looking outside the company. About half of the medicines in Glaxos labs came from partnerships and acquisitions, Slaoui said. He declined to name therapeutic areas the company is targeting in its search for licensing and partnership deals.
Witty has overhauled internal research to try to make it more efficient, shedding unfruitful projects that once made up 25 percent of Glaxos pipeline. Hes also trying to fuel innovation by forcing the companys scientists to compete with one another for funding as if they worked at start-up companies.
Waiting for Results
“They definitely are shaking up R&D and streamlining it, but I dont think theyve done any particularly amazing deals in the R&D area,” said Simon Mather, a London-based analyst for WestLB AG who has an “add” rating on the stock. “Witty is reorganizing the whole of R&D; now were just waiting for the fruits of that. It does take time.”
About 80 percent of projects that Glaxo has licensed since 2003 are “progressing,” compared with 40 percent of those that the company decided against pursuing, said the executive, who declined to elaborate on which competitors were desperate.
Witty is pushing the company to pursue drugs that it wouldnt have in the past, said Slaoui. “Early next month we will be announcing us entering into orphan or even super-orphan medicines,” he said.
Regulators award the orphan designation to treatments aimed at rare diseases, giving the medicines a speedier review and up to seven years of market exclusivity in the U.S.
HIV, Red Wine
Shire Plc, based in Basingstoke, England, is one of Europes biggest makers of orphan drugs, but Slaoui ruled out an acquisition without elaborating. “We are not going to buy Shire,” he said.
A review of early Glaxo projects in May identified especially promising drugs in HIV, inflammation and sirtuins, enzymes found in red wine that are thought to slow the effects of aging, Slaoui said. Glaxo last year paid $720 million for Sirtris Pharmaceuticals Inc., which is developing sirtuin-based drugs in mid-stage clinical tests for cancer, diabetes and other diseases.
“We expect late 2010 or early 2011 is going to be quite an interesting time” for sirtuins in “several indications,” he said.
Not everything makes the cut. Under Witty, Glaxo scrapped development of a diabetes drug that was in a family of medicines called SGLT2-inhibitors that Slaoui said proved “very successful” in mid-stage trials. AstraZeneca Plc and partner Bristol-Myers Squibb Co. developed the first SGLT2 drug, called dapagliflozin, which is in late-stage tests that will be reported next week at a European diabetes conference.
Lilly, Daiichis Anti-clotting Drug Has Lower Costs Than Plavix
The Lilly-Daiichi drug, Effient, had an average cost savings of $221 per patient over the course of a 15-month study, said David Cohen, director of research at Saint Lukes Mid American Heart Institute in Kansas City, Missouri, in a presentation today at a heart-device conference. The savings figures took into account the cost of hospital care, heart surgeries and other procedures, along with the cost of the drugs themselves, said Cohen, the studys lead investigator.
Effient was approved in the U.S. in July for the prevention of heart attacks and strokes in patients with acute coronary syndrome who are undergoing a procedure, known as angioplasty, to repair or unblock blood vessels. The Lilly-Daiichi drug competes with Plavix, which had sales of $8.2 billion last year for New York-based Bristol-Myers and Paris-based Sanofi.
“We live in a world where there is significant concern about health care costs,” said LeRoy LeNarz, senior medical director of cardiovascular care at Indianapolis-based Lilly, in a telephone interview. “That $221 has a significant impact when you are improving patient outcomes versus the standard of care and reducing costs.”
Larger Study
The cost analysis, presented at the Transcatheter Cardiovascular Therapeutics meeting, was part of a larger, 13,608-patient study, known as Triton, that found that Effient was more effective than Plavix at reducing the number of deaths from heart disease. The Effient patients, however, had more cases than Plavix of excessive bleeding that led to death, according to study results presented in November 2007 at an American Heart Association scientific meeting.
The total costs for heart patients on Effient was $26,067 over 15 months compared with $26,288 for those on Plavix, according to the 6,700-patient study, funded by Lilly and Daiichi Sankyo. Patients who took Effient incurred lower hospital costs and had fewer surgical procedures, such as repeat angioplasties, although drug costs were higher. Effient costs $166 per month compared with $141 for Plavix, the researchers said.
Effient began selling in April in Europe under the alternative spelling “Efient.”
Plavix, which is Bristol-Myers best-selling drug, loses its patent protection in 2011, and is likely to be available in lower-cost generic versions. For purposes of the cost study, Cohen also projected that generic Plavix will cost about $1 a day.
Assuming a $30 monthly cost for the generic version of Plavix, Lilly-Daiichi drugs “higher cost may be justified based on projected gains in long-term survival,” Cohen said.
Precancer? Earliest Cancer? Milk-duct Cells Vexing
A less scary formal name could help, says a new report that urges removing the word “carcinoma” from the diagnosis of a common growth in milk ducts.
More than 50,000 women a year are diagnosed with DCIS, or ductal carcinoma in situ. This is not invasive breast cancer, the kind that kills. The abnormal cells havent left the milk duct to penetrate breast tissue.
Still, its removed because it is a risk factor for developing true invasive cancer later. Treatment works. Only about 2 percent of DCIS patients die of breast cancer in the next 10 years.
The problem: Doctors dont have a good way to tell which women are at risk of DCIS returning as true cancer and which arent. So there are vast differences in how its treated, from a simple small surgery to a full radiation-and-chemo blast. Some women even have the healthy opposite breast removed protectively.
Its time for major research to answer the risk question and determine who could safely skip harsh treatment and who really needs it, concluded specialists convened by the National Institutes of Health to assess DCIS.
And changing the name, the panel concluded, will help doctors convey that while this growth shouldnt be ignored, theres time to carefully consider the options.
“The name carries with it such a disproportionate level of anxiety relative to the relatively indolent nature of the disease,” said Dr. Carmen Allegra, a University of Florida oncologist who chaired the panel.
The panel didnt offer an alternative name.
But the issue is similar to cervical cancer, where abnormal cells form on the surface of the cervix before eventually invading. What doctors now call a precancerous condition – and classify with various levels of severity – they once termed cervical carcinoma in situ.
With DCIS, “this is a complex area we know less about,” said Dr. Susan Reed of Seattles Fred Hutchinson Cancer Research Center. “We dont have a clear understanding of how to say, for example, Mrs. Jones, your risk to get an invasive breast cancer in the next 10 years would be some percentage.”
Obesity Might Become Top Cancer Cause
Being overweight or obese accounts for up to 8 percent of cancers in Europe. Experts said that figure is poised to increase substantially as the obesity epidemic continues, and as major causes of cancer, such as smoking and hormone replacement therapy for menopausal women, drop dramatically.
“Obesity is catching up at a rate that makes it possible it could become the biggest attributable cause of cancer in women within the next decade,” said Andrew Renehan, a cancer expert at the University of Manchester. Renehan presented his findings to a joint meeting of the European Cancer Organisation and the European Society for Medical Oncology in Berlin on Thursday.
Renehan and colleagues designed a model to estimate the number of cancers that could be blamed on being fat in 30 European countries. In 2002, they calculated that 70,000 cases of cancer out of about 2 million cancer cases were attributable to being overweight or obese. By 2008, the number had jumped to at least 124,000.
Colorectal cancer, breast cancer in menopausal women and endometrial cancer accounted for 65 percent of all cancers linked to being fat. Renehan said that in the U.S., some studies found obesity was responsible for up to 20 percent of cancers.
Experts said the results should help shape future cancer policies across Europe.
“Being overweight or obese is likely to be one of the biggest single causes of cancer after smoking,” said Lucy Boyd, an epidemiologist at Cancer Research United Kingdom who was not linked to the research.
Scientists arent sure why being fat boosts your cancer risk, but suspect it is connected to hormones. As people become fatter, they produce more hormones like estrogen that help tumors grow. People with big bellies also have more acid in their stomachs, which can lead to stomach, intestinal or esophageal cancer.
Still, not all experts said obesity would produce skyrocketing cancer rates in the near future.
“It is not likely (obesity) will have as severe an effect as smoking,” said Jan Coebergh, a professor of cancer surveillance at Erasmus University, who has done similar research. Coebergh expected it would take a few decades before rounder Europeans would see a parallel rise in cancer, since the disease often takes years to develop.
Still, scientists called for more measures to fight obesity and the cancers it might cause.
Renehan said new strategies were needed to help people stay slim. “We need to find the biological mechanism to help people find other ways of tackling obesity,” he said. “Just telling the population to lose weight obviously hasnt worked.”
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http://www.ecco-org.eu
High-fructose Diet Raises Blood Pressure In Middle-aged Men
Men in the study who ate a high-fructose diet had their blood pressure rise about 5 percent after two weeks, while those who also were given a gout treatment increased less than 1 percent, study author Richard Johnson said. Eating great amounts of fructose without the treatment also raised the risk of developing metabolic syndrome, a group of risk factors associated with the development of heart disease and diabetes.
The study is one of the first to show that consuming foods high in fructose raises blood pressure in people, Johnson said. The gout treatment lowered the bodys uric acid that is linked at elevated levels to high blood pressure, diabetes and heart disease.
“Reduce your sugar intake,” Johnson, a professor of medicine at the University of Colorado, Denver in Aurora, said yesterday in a telephone interview. “This data would suggest that too much sugar and high fructose corn syrup may not be a good thing.”
Johnson said larger trials were needed to confirm the findings, particularly before treating people with any drugs including the gout medicine, allopurinol.
Exciting Data
“Were not ready to lower uric acid as a means to lower blood pressure,” said Johnson, who worked with Santos Perez- Pozo, a kidney specialist and lead author of the research in Minorca, Spain. “It is exciting data that suggests uric acid may have a role in hypertension.”
The study, which was funded by the National Institutes of Health, will be presented today at the American Heart Associations annual conference on high blood pressure in Chicago.
Fructose is one of several sugars in food and makes up about half of all the sugar molecules in table sugar and in high-fructose corn syrup, according to background information from the American Heart Association. The syrup often is used as a sweetener in packaged food products. Fructose is the only common sugar known to increase uric acid levels, the heart association said.
The study examined 74 adult men in Spain with an average age of 51. The men were given 200 grams (7.05 ounces) a day of fructose in addition to their regular diet. In the U.S., most adults consume about 50 grams to 70 grams of fructose a day.
Blood Pressure
Half of the men in the study were assigned to receive the generic gout drug allopurinol, while the other half were given a placebo. After two weeks, those in the fructose-placebo group had an increase of 6 mm Hg in their systolic blood pressure and a 3-mm Hg rise in their diastolic blood pressure, the researchers found. Systolic refers to the top number in the blood-pressure ratio and shows the pressure when the heart beats, while diastolic is the lower number that measures the pressure between the heart beats.
Those getting the high-fructose diet who also were given allopurinol didnt show significant increases in their systolic or diastolic blood pressures, the study showed.
Metabolic Syndrome
The incidence of metabolic syndrome as defined in the U.S. more than doubled to 44 percent of the group getting the high- fructose intake without allopurinol. The syndrome is defined as having at least three of five risk factors including increased waist circumference, high blood pressure and high fasting-blood sugar. Those in the group receiving allopurinol didnt experience a rise in metabolic syndrome incidence, possibly because the gout drug stopped their blood pressure from rising, the authors said.
Most sugar consumption in the U.S. comes from sweetened drinks and foods high in sugar or high fructose corn syrup, Johnson said.
The research results suggest its possible that lowering uric acid levels could become a routine practice in the future, much like lowering cholesterol.
“This could become a risk factor that is modifiable and that lowering it could be of considerable benefit,” Johnson said. “However we still need more studies to prove it.”