Malaria Strain Resists Drugs, May Threaten Millions, Study Says
Treatments derived from artemisinin, the basis of the most effective anti-malaria drugs, took almost twice as long to clear the parasites that cause the disease in patients in western Cambodia as in patients in northwestern Thailand, according to a study published today in the New England Journal of Medicine.
The delay in parasite clearance times shows the drugs are losing their power against the disease in Cambodia, the study said. The failure of artemisinin-based treatments would be “disastrous” for global efforts aimed at curbing the death and disease wrought by the malady, said Arjen Dondorp, who led the study at the Mahidol Oxford Research Unit in Bangkok.
“There is no question that this is resistance to artemisinin,” Carlos Campbell, a malaria expert with the Seattle-based Program for Appropriate Technology in Health, or PATH, wrote in an editorial accompanying the study. “History warns us that it will intensify and spread unless containment steps are taken.”
Scientists have known for decades that Pailin, near Cambodias border with Thailand, is a breeding ground for drug- resistant malaria. Chloroquine and Roche Holding AGs Fansidar started to fail there in the 1950s and 1960s, before becoming ineffective elsewhere, according to the study. The WHO, with $23 million from the Bill & Melinda Gates Foundation, is coordinating efforts to prevent artemisinin-resistant malaria from spreading to Africa, which has 90 percent of the worlds cases of the disease.
Delayed Clearance
Delayed parasite clearance times have been observed in southern Cambodia since the studys completion, a sign the resistant strain has already spread within the country, Dondorp said in a phone interview.
Dondorp and colleagues treated 40 people in Pailin and another 40 in Wang Pha in Thailand, with artesunate, a form of artemisinin.
In Pailin, the drug took a median of 84 hours to clear the parasite from patients blood, compared with 48 hours, the standard, in Wang Pha, according to the study. After three days, artesunate failed to clear the parasite in 55 percent of patients in Pailin, compared with 8 percent in Wang Pha.
Widespread artemisinin resistance “would cause millions of deaths, without exaggeration,” Dondorp said in an interview in January.
Deadly Disease
Malaria strikes about 250 million people each year and kills more than 880,000, mostly children under 5, according to the WHO. Its the worlds third-deadliest infectious disease, behind AIDS, which results in about 2 million deaths each year, and tuberculosis, which kills 1.6 million people annually, the Geneva-based WHO said.
The latest findings confirm those of earlier, inconclusive studies that suggested artesunate was losing potency in the region. Until now, researchers werent sure whether slowing cure rates were due to the failure of artesunate or another less powerful drug, mefloquine, thats usually given with it.
No Alternative
Campbell noted that there isnt an alternative class of malaria drugs to replace artemisinin derivatives. Artemisinin- based medications work by giving malaria a short, sharp shock, clearing most of the parasites from the blood within hours. The drawback is they dont remain in the body. The WHOs guidelines recommend combining the drug with one of several less-powerful, longer-lasting medicines that eradicate stragglers.
Those other drugs, such as mefloquine, may cause adverse effects including nausea, vomiting and nightmares. When the two drugs are sold side by side, rather than combined in a single pill, some patients take only the artemisinin to avoid unpleasant symptoms, paving the way for relapses and drug resistance.
Counterfeit drugs containing suboptimal amounts of artesunate may also have contributed to the development of the resistant strain, Dondorp said.
Pfizer Suit On Neurontin Is Dropped By Suicide Victims Family
Susan Bulgers family agreed to dismiss the suit after an anonymous donor offered to put money in a trust for her 10-year- old daughter, Regina, said Mark Lanier, the familys lawyer. The trial began July 27 and was scheduled to run three weeks in federal court in Boston.
The suit was the first of about 1,200 involving Neurontin. The family claimed Pfizer, the worlds largest drug company, promoted the medication for unapproved uses and didnt warn it could increase the risk of suicide until forced to do so by the government. Pfizer said Bulger had a history of drug abuse and had made six suicide attempts before taking her life in 2004.
“We are pleased to have been vindicated in this case,” Jeffrey Kindler, chief executive officer of New York-based Pfizer, said in a phone interview on Bloomberg Television today. Neurontin has been “prescribed to treat millions of patients safely and effectively for many, many years and its been widely studied for more than two decades,” he said.
The next Neurontin trial is set to start March 29 in Boston federal court, while another case in Tennessee may be tried earlier, Lanier said. The lawsuits claim Pfizer should have warned patients and doctors that Neurontin can increase suicidal thoughts.
Outrageous
Kindlers comments are “outrageous,” Lanier said. “All Pfizer got today was a six-month stay of execution. We have 1,200 more of these cases to go.”
The anonymous donor was a plaintiffs lawyer who wasnt involved in the case, said Lanier, a friend of the donors. “It was the best thing for the family,” said David Egilman, a Brown University medical school professor who serves as the Bulgers spokesman.
The U.S. Food and Drug Administration in December required all makers of epilepsy drugs, including Neurontin, to add a suicide-risk warning to their labels. Pfizer contends there is no link to Neurontin use and suicide.
The company hasnt paid anything in exchange for dismissal of the suit, Amy W. Schulman, the drugmakers general counsel, said in an e-mailed statement. Pfizer “continues to believe that there is no scientifically reliable evidence that Neurontin causes suicidal behavior,” she said.
Very Difficult Case
The Bulgers lawsuit was “a very tough case” for the plaintiffs because of her “personal history,” U.S. District Judge Patti B. Saris in Boston said in a July 20 pretrial hearing.
The family claimed Pfizers marketing of Neurontin for unapproved, or off-label, uses played a role in her doctors prescribing the drug. Bulger took the drug, approved to treat epilepsy, for mood swings and arthritis pain.
Warner-Lambert paid $430 million in 2004 to resolve off- label marketing allegations involving Neurontin by the U.S. Justice Department. Pfizer said the settlement involved actions before the company bought Warner-Lambert and Bulgers doctors didnt prescribe the drug because of off-label marketing.
Pain Reliever
Her doctors prescribed Neurontin because it has been shown to help with pain, isnt addictive and has few side effects, Pfizer lawyer William Ohlemeyer said at trial.
The prescriptions were “based on the doctors background and experience and not what Pfizer or Warner-Lambert told them,” he said.
Pfizer fell 28 cents, or 1.8 percent, to $15.75 in New York Stock Exchange composite trading. The stock has declined 11 percent in 2009, after falling for two years.
The case is Bulger v. Pfizer Inc., 1:07-cv-11426, U.S. District Court, District of Massachusetts (Boston). The suit is part of In Re Neurontin Marketing, Sales Practices and Products Liability Litigation, MDL 1629.
Glaxo to Market Amgen Osteoporosis Drug In Europe (updat3)
Glaxo will pay $120 million initially for near-term milestones to share profits in Europe and sell the drug in countries where Thousand Oaks, California-based Amgen doesnt have a presence, including China, Brazil, India and South Korea, the companies said in a statement. Amgen will market the drug in the U.S. and Canada and retain rights to sell it for cancer in Europe once approved.
Amgen is looking to denosumab to generate revenue and replace declining sales of medicines that treat anemia and arthritis. Denosumab, designed to be injected twice a year, will be reviewed Aug. 13 by U.S. Food and Drug Administration advisers as a treatment for osteoporosis in post-menopausal women. It also is being tested for use against a variety of cancers.
“When you talk about the osteoporosis setting you are dealing with a very competitive market against a well-known generic, so a sure-footed marketing and partnering strategy will be critical,” said John Sonnier, an analyst with William Blair & Co. in Chicago, in a telephone interview before the announcement.
Amgen gained $1.65, or 2.7 percent, to $62.42 at 4 p.m. New York time in Nasdaq Stock Market composite trading. Glaxo rose 8.5 pence to 1,171.5 pence in London trading.
$2 Billion
Denosumab may grab $2 billion of the $8.7 billion annual market for osteoporosis by 2018, according to a June report by the sales research firm Decision Resources, based in Waltham, Massachusetts.
Glaxo beat 10 other companies for the partnership, Amgen executives said on a conference call yesterday.
“Not all biopharmaceutical companies are targeted at therapeutic areas like osteoporosis that have such a sizable potential,” Eddie Gray, head of Glaxos European pharmaceuticals division, said today in an interview. “We were able to convince Amgen that that our experience was extremely valuable and theyve taken that view as well. Weve also identified biopharmaceuticals as an area we havent been traditionally involved in.”
The drug may cost patients about $1,200 a year, Yaron Werber, an analyst at Citigroup in New York, said yesterday in a telephone interview. Assuming Amgen receives a 25 percent royalty on sales outside the U.S., denosumab can generate $958 billion worldwide by 2012, Werber said. The companies didnt disclose the specifics of how profits will be shared.
Partner in Europe
“Our collaboration with GlaxoSmithKline will help Amgen bring the promise of denosumab to patients in Europe and other parts of the world more effectively than if we commercialized the drug globally on our own,” said Amgen Chief Executive Officer Kevin Sharer in the statement.
More than 200 million people worldwide, including 25 million in the U.S., have osteoporosis, a disease that causes bones to deteriorate and break. The condition mostly affects elderly women.
Because the most common treatment, Merck & Co.s generic Fosamax, is a daily pill, Amgen “will need to change the way doctors think to get them to use an injectable for osteoporosis,” said Chris Raymond, an analyst with Robert W. Baird & Co. in New York, in a telephone interview.
In Line
Amgen will charge about $850 a year for denosumab, in line with other brand-name medicines for osteoporosis, said Eric Schmidt, an analyst with Cowen & Co. in New York, in a note to clients. He estimates the drug will generate more than $1 billion a year by 2015.
Fosamax had $3 billion in sales in 2007 before cheaper generic copycats came on the market and cut into revenue, according to data compiled by Bloomberg.
Amgen is betting doctors and patients want an alternative that adds benefit beyond those offered by Fosamax and other osteoporosis pills known as bisphosphonates. Those include Boniva, sold by Basel, Switzerland-based Roche Holding AG and Glaxo, Novartis AGs Reclast and Procter & Gamble Co.s Actonel.
$1 Billion
Swine Flu Shot In U.s. May Rely On Crisis Use Of Additives
The ingredients, known as adjuvants, may be added for the first time to flu shots in the U.S. Health officials, meeting today at the U.S. Centers for Disease Control and Prevention in Atlanta, plan to discuss use of the additives, and may also recommend who should be first to receive the limited amount of vaccines drugmakers say they will begin delivering in October.
The U.S. Health and Human Services Department declared a public health emergency over swine flu in April, and the Food and Drug Administration has the power to allow the use of unapproved medical products during such a crisis. The U.S. has been slow to approve the use of adjuvants because of safety concerns, and for fear of giving Americans an excuse to avoid getting the shots, said John Treanor, a University of Rochester researcher.
“The question is, do you really feel comfortable throwing this new thing into the mix and do you really need to?” said Treanor, a professor of medicine, microbiology and immunology at the school in Rochester, New York. “I myself, if I had to do it, would really wrestle with that decision.”
The CDC agreed to pay London-based Glaxo and Novartis, based in Basel, Switzerland, more than $415 million for adjuvants that could be added to the swine flu vaccines, according to a July 13 statement.
Mice Studies
A safety concern was raised in 2004 when researchers at the University of Florida in Gainesville reported that mice injected with oils used in the adjuvants developed conditions of the type that occur when the bodys immune system produces an excessive protective reaction. Similar reactions havent been seen in humans.
MF59, made by Novartis, has been given to more than 40 million people, mostly adults, to prevent seasonal flu, according to the company. Glaxos adjuvant has proven safe and effective in clinical trials with 39,000 people, said Lisa Behrens, a spokeswoman for the company, in an e-mail. Glaxo will conduct more studies and continue to monitor safety after the vaccines are in use, she said.
Under the U.S. health emergency, the FDA may authorize the use of unlicensed vaccines, according to Peper Long, an agency spokeswoman. The FDA convened an advisory committee July 23 to consider what trials are necessary for the vaccines approval. Advisory committees consist of medical experts who provide guidance to the agency.
Race to Make Shots
Swine flus full force may reach the U.S. earlier than the typical flu season, according to the CDC. Vaccine makers are racing to make shots by mid-October, when cases are expected to rise in the northern hemisphere, fueled by cooler temperatures and the return of pupils to close quarters of classrooms.
The World Health Organization, based in Geneva, has said the H1N1 influenza, as the pandemic flu is known, is moving with “unprecedented speed.” The flu spread farther globally in less than six weeks than previous pandemics have in more than six months, the Geneva-based agency said on its Web site on July 17. Global health authorities have stopped counting the number of cases and the CDC says more than 1 million people Americans have been sickened by the virus.
Mixing Oil, Water
The adjuvants are mixes of oil and water that — by stimulating the immune system — offer a way to boost the bodys response to antigen. Adjuvants, whose effectiveness vary by flu strain, may boost the strength of the antigen as much as 10- fold, as was the case with a bird flu vaccine approved in Europe, said Treanor, of the University of Rochester. By adding an adjuvant the same amount of antigen can be used to treat more people, he said.
“Until GlaxoSmithKline and Novartis can show me it wont harm a rat or guinea pig, I think its a bad idea to give it to humans,” Vicky Debold, a registered nurse with a Ph.D. in public health, who is a member of the FDAs advisory committee for reviewing vaccines, said July 27 in an interview.
Tremendously Well
The U.S. never had to consider the risks of an adjuvant because regular flu vaccines were deemed to have “worked so tremendously well,” said Lone Simonsen, research director in the department of global health at George Washington University in Washington.
“We have had a safe experience with the MF59-adjuvanted vaccine in Italy and Spain for many years now,” Simonsen said. “That experience we can lean on. Thats going to be the best data we have in time for using adjuvanted vaccines.”
CSL Ltd., which has a $180 million order to supply bulk H1N1 antigen to the U.S. government, decided against boosting its vaccine with an adjuvant, preferring to use a formulation more closely resembling the seasonal flu shot, said Mary Sontrop general manager of the Melbourne-based companys biotherapies unit.
Fda Concludes Mercury In Dental Fillings Not Risky
It was something of an about-face for the Food and Drug Administration, which last year settled a lawsuit with anti-mercury activists by posting on its Web site a precaution saying questions remained about whether the small amount of mercury vapor the fillings can release were enough to harm the developing brains of fetuses or the very young.
On Tuesday, the FDA said its final scientific review ended that concern. Still, the agency did slightly strengthen how it regulates the fillings, urging dentists to provide their patients with a government-written statement detailing the mercury controversy and what science shows.
“The best available scientific evidence supports the conclusion that patients with dental amalgam fillings are not at risk for mercury-associated adverse health effects,” said Dr. Susan Runner, FDAs dental products director.
Anti-mercury activists accused the agency of bowing to the dental industry and said theyd go back to court to try to force a change.
“FDA broke its contract and broke its word that it would put warnings for children and unborn children,” said Charles Brown of Consumers for Dental Choice. “This contemptuous attitude toward children and the unborn will not go unanswered.”
Too much mercury can harm the brain. It has made headlines in recent years as scientists have warned that some types of seafood contain enough to harm a fetus or young child.
Used since the 1800s, amalgam fillings are a mix of a different kind of mercury – a kind the body absorbs differently – with silver, copper and tin to harden it.
Tuesday, the FDA took the regulatory step of formally classifying amalgam fillings as a Class II or “moderate risk” medical device to ensure that dentists handle the mercury properly – using adequate ventilation – but to allow the allergy warning. Until now, the FDA had classified the fillings ingredients separately.
The practical effect of that technical change? The FDA released its review of 200 scientific studies that found no risk to adults or children over 6 from the fillings.
What about pregnant women or younger children? Tuesdays ruling supersedes the precaution from last years lawsuit settlement, Runner said.
The FDA found that while there have been only a handful of rigorous studies comparing young children given either amalgam fillings or mercury-free tooth-colored resin composite ones, those studies havent detected any brain problems. Runner cited additional evidence concluding that babies and young children would be exposed to amounts well below safety limits.
But the statement dentists are urged to share with patients does raise the issue so that people who are concerned about the mercury can discuss an alternative.
Amalgams now account for about 30 percent of U.S. fillings, their popularity dropping in favor of tooth-colored alternatives. But they remain the cheapest filling and dentists say there are some conditions that demand amalgams, such as spots on back teeth that wont stay dry long enough for composite fillings to bond.
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On the Net:
FDA: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/default.htm
Study: Tanning Beds as Deadly as Arsenic
A new analysis of about 20 studies concludes the risk of skin cancer jumps by 75 percent when people start using tanning beds before age 30. Experts also found that all types of ultraviolet radiation caused worrying mutations in mice, proof the radiation is carcinogenic. Previously, only one type of ultraviolet radiation was thought to be lethal.
The new classification means tanning beds and other sources of ultraviolet radiation are definite causes of cancer, alongside tobacco, the hepatitis B virus and chimney sweeping, among others.
The research was published online in the medical journal Lancet Oncology on Wednesday, by experts at the International Agency for Research on Cancer in Lyon, the cancer arm of the World Health Organization.
“People need to be reminded of the risks of sunbeds,” said Vincent Cogliano, one of the cancer researchers. “We hope the prevailing culture will change so teens dont think they need to use sunbeds to get a tan.”
Most lights used in tanning beds give off mainly ultraviolet radiation, which cause skin and eye cancer, according to the International Agency for Cancer Research.
The classification of tanning beds as carcinogenic was disputed by Kathy Banks, chief executive of The Sunbed Association, a European trade association of tanning bed makers and operators.
“The fact that is continuously ignored is that there is no proven link between the responsible use of sunbeds and skin cancer,” Banks said in a statement. She said most users of tanning beds use them less than 20 times a year.
But as use of tanning beds has increased among people under 30, doctors have seen a parallel rise in the numbers of young people with skin cancer. In Britain, melanoma, the deadliest kind of skin cancer, is now the leading cancer diagnosed in women in their 20s. Normally, skin cancer rates are highest in people over 75.
Previous studies found younger people who regularly use tanning beds are eight times more likely to get melanoma than people who have never used them. In the past, WHO warned people younger than 18 to stay away from tanning beds.
Cogliano cautioned that ultravoilet radiation is not healthy, whether it comes from a tanning bed or from the sun. The American Cancer Society advises people to try bronzing or self-tanning creams instead of tanning beds.
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On the Net:
Study: Pregnant Women With Swine Flu More At Risk
While experts dont know if pregnant women are more susceptible to swine flu, they say once pregnant women are infected, they have a higher risk of complications.
Researchers at the U.S. Centers for Disease Control and Prevention analyzed the first 34 U.S. cases, including 6 deaths, of swine flu in pregnant women from April to mid-June.
They concluded that pregnant women suspected of having swine flu should be given Tamiflu as soon as possible, even before tests confirm the diagnosis. The experts also recommended that pregnant women be among the first in line when a vaccine is expected to be ready in the fall.
The study was published online Wednesday in the medical journal, the Lancet.
Like the general population, most pregnant women who get swine flu only have mild symptoms like fever and a cough, according to the World Health Organization. Denise Jamieson of the U.S. CDC, the studys lead researcher, said the agency doesnt recommend any special precautions for pregnant women to avoid catching the virus.
But if pregnant women do get swine flu, Jamieson said doctors need to act fast, preferably within 48 hours of developing symptoms.
“The message is dont delay appropriate treatment because shes pregnant,” she said.
Health officials at WHO have previously reported that some doctors were reluctant to give the antiviral drug Tamiflu to pregnant women. While safety data on Tamiflu use in pregnant women is limited, Jamieson said it appears relatively safe.
Of the six fatal cases in the Lancet study, Jamieson said nearly all had viral pneumonia before experiencing acute respiratory problems, and were put on ventilators before they died. Aside from one woman who had asthma and another who was obese, Jamieson said the women were essentially healthy.
U.S. guidelines list pregnant women as a high-priority group for pandemic vaccines, although that is for vaccines without adjuvants, ingredients used to stretch a vaccines active ingredient.
In the U.S., flu vaccines dont have adjuvants, but in Europe, many do. There is little data on how safe vaccines with adjuvants are in pregnant women.
Cecilia Nwobi, a London-based lawyer pregnant with her third child, said she hasnt yet decided if she will get a swine flu shot.
Advice from European authorities has varied widely – some British and Swiss officials even initially advised that women consider delaying having children until the pandemic ends – even though that might be more than a year away.
Britains department of health quickly backed away from that guidance, although they still say pregnant women may want to avoid crowded places.
“The most important measures are for pregnant women to observe good hand and respiratory hygiene,” said Dr. Boon Lim, a spokesman for Britains Royal College of Obstetricians and Gynaecologists. “But if the situation worsens, further advice may be necessary.”
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On the Net:
Amgen Reaches Contract With Glaxosmithkline to Sell Bone Drug
London-based Glaxo will pay $120 million initially for near-term milestones to share profits in Europe, and sell Amgens drug in countries where the Thousand Oaks, California- based company doesnt have a presence including China, Brazil, India and South Korea, the companies said in a statement. Amgen will market the drug in the U.S. and Canada and retain rights to sell it for cancer in Europe once approved.
Amgen is looking for denosumab to generate revenue and replace declining sales of its core medicines that treat anemia and arthritis. Denosumab, designed to be injected twice yearly, will be reviewed Aug. 13 by U.S. Food and Drug Administration advisers as a treatment for osteoporosis in post-menopausal women. It also is being tested against a variety of cancers.
“When you talk about the osteoporosis setting you are dealing with a very competitive market against a well-known generic, so a sure-footed marketing and partnering strategy will be critical,” said John Sonnier, an analyst with William Blair & Co. in Chicago, in a telephone interview before the announcement.
$2 Billion
Denosumabs annual revenue may reach $2 billion of the $8.7 billion market for osteoporosis by 2018, according to a June report by the sales research firm Decision Resources, based in Waltham, Massachusetts.
“This is a cancer and renal company, and they have been in partnership discussions for a while now,” Yaron Werber, an analyst at Citigroup in New York, said yesterday in a telephone interview.
The drug may cost patients about $1,200 a year, Werber said. Assuming Amgen receives a 25 percent royalty on sales outside the U.S., denosumab can generate $958 billion worldwide by 2012, Werber said. The companies didnt disclose the specifics of how profits will be shared.
“Our collaboration with GlaxoSmithKline will help Amgen bring the promise of denosumab to patients in Europe and other parts of the world more effectively than if we commercialized the drug globally on our own,” said Amgen Chief Executive Officer Kevin Sharer in the statement.
Partner in Europe
Jim Daly, an Amgen senior vice president, said at a Nov. 7 investor meeting that a sales force of 800 to 1,500 would be needed to promote the drug in Europe, and 500 to 1,000 representatives would be needed in the U.S.
More than 200 million people worldwide, including 25 million in the U.S., have osteoporosis, a disease that causes bones to deteriorate and break. The condition mostly affects elderly women.
Amgen will charge about $850 a year for denosumab, in line with other brand-name medicines for osteoporosis, said Eric Schmidt, an analyst with Cowen & Co. in New York, in a note to clients. He estimates the drug will generate more than $1 billion a year by 2015.
Competitors
Fosamax had $3 billion in sales in 2007 before cheaper generic copycats came on the market, diminishing revenue, according to data compiled by Bloomberg.
Amgen is betting doctors and patients want an alternative that adds benefit beyond those offered by Fosamax and other osteoporosis pills known as bisphosphonates. Those include Boniva, sold by Basel, Switzerland-based Roche Holding AG and Glaxo, Novartis AGs Reclast and Procter & Gamble Co.s Actonel.
Boniva generated $434.3 million in sales last year for London-based Glaxo and $1.02 billion for Roche. Actonel generated more than $1 billion last year, Procter & Gamble spokeswoman Tom Millikin said in a May 13 interview. Reclast, also marketed as Aclasta outside the U.S., had $254 million in revenue last year, according to preliminary annual sales results released by Novartis on Jan. 28. The medicine was approved in August 2007 by U.S. regulators and in October that year by European officials.
Amgens drug is faster acting, easier to give to patients, and free of side effects found with bisphosphonates, studies so far have shown. Fosamax and similar medications can, in some cases, make jaw bones crumble, and are tied to nausea, diarrhea and constipation, doctors say.
Obesity Medical Costs Balloon to $147 Billion, Study Finds
Each obese patient costs health insurers and government programs $1,429, or 42 percent, more a year than a normal-weight individual in 2006, according to the analysis of health expenses released today by the journal Health Affairs. In 1998, the medical costs of obesity were estimated to have reached $78.5 billion.
President Barack Obama has said his administration wants to control the rising cost of health care in part through preventive medicine programs, such as those to help people lose weight or quit smoking. Medicare, the government run program for the elderly and disabled, spent $7 billion on obesity-related prescriptions drugs, such as those to treat diabetes, high cholesterol and blood pressure, the study said.
“Although health reform may be necessary to address health inequities and rein in rising health spending, real savings are more likely to be achieved through reforms that reduce the prevalence of obesity and related risk factors, including poor diet and inactivity,” said the studys authors. “These reforms will require policy and environmental changes that extend far beyond what can be achieved through changes in health care financing and delivery.”
Expanding Obesity Rate
The incidence of obesity, a major cause of diabetes, stroke and heart attacks, has more than doubled in the past 30 years, according to the Centers for Disease Control and Prevention. About 32 percent of American adults are obese, according to data from the CDCs Web site. A person is obese if their body mass index is greater than 30 or about 186 pounds for a person who is five feet, six inches tall.
Without obesity, spending by the government-funded Medicaid program for the poor would be 8.5 percent less and Medicare would be lowered by 11.8 percent, the study said.
Researchers analyzed data between 1998 and 2006 from the government-sponsored Medical Expenditure Panel Survey, which collects information on health services that Americans use, how frequently they use the services and the cost. The study was conducted by researchers at RTI International in Research Triangle Park, North Carolina, the CDC in Atlanta, and the Agency for Healthcare Research and Quality in Rockville, Maryland.
The study was funded by the Centers for Disease Control and Prevention.
Drugmakers May Fund $100 Million Ad Campaign On Health Overhaul
The Pharmaceutical Research & Manufacturers of America, the industry lobbying group, discussed funding the advertising campaign during a meeting last week in Washington, the person said. PhRMA senior vice president Ken Johnson said no decision has been reached on the groups campaign strategy for when Congress reconvenes after the August recess.
PhRMA will be running television commercials in August, in states where pharmaceutical companies have operations, asserting the importance of the drug industry for the economy, Johnson said. The drugmakers, by offering to lower drugs costs by $80 billion over 10 years, became one of the first industries to reach an agreement with the Obama administration in its efforts to revamp the health-care system. The drugmakers said they would oppose legislation allowing the government to negotiate prices on medicines sold through the U.S. drug program of Medicare.
“We are always preparing to fight back against bad public policy that would hurt patients and our ability to discover and develop new life saving medicines,” Johnson said July 24 in a telephone interview.
Ad Campaign May Grow
Two people familiar with the discussions in Washington said the amount of money put into ads may increase to $120 million.
Washington-based PhRMA represents 28 drugmakers, including New York-based Pfizer Inc. and GlaxoSmithKline Plc, with headquarters in London.
The content of the ads will depend on the legislation crafted in the House and Senate, where different procedural and political dynamics are at work.
Representative Henry Waxman, a California Democrat and chairman of a House committee writing health-care legislation, said this month that the deal Pfizer and other companies made to discount brand-name drugs for the elderly with gaps in Medicare prescription coverage was “really a Senate agreement.”
The industrys $80 billion pledge was negotiated with Senator Max Baucus, a Montana Democrat who is chairman of the Senate Finance Committee and senior White House aides. Baucus is struggling to reach a bipartisan deal on his panel before the Aug. 7 recess.
Democratic leaders postponed a vote by the full Senate until September. Leaders in the House, which is scheduled to adjourn July 31, are fighting to contain a party split over the $1 trillion cost of the proposed health-care bill.
Drug Imports
“We are strongly against reimportation from a safety standpoint,” Richard T. Clark, chief executive officer of Merck & Co., said July 21 in a telephone interview. “If it is an issue, we will have to fight that because we think that is the wrong thing to do from a patient standpoint.”
Pfizer Chief Executive Officer Jeffrey Kindler said the industry supports the current health-overhaul proposal by the Obama administration. Pfizer opposes importing drugs from Canada or allowing the U.S. government to directly negotiate Medicare Part D drug prices.
Such pricing policies would “provide disincentives to the investment in research necessary to produce life-saving treatments,” Kindler said in a July 22 telephone interview.
Merck and Pfizer spokespeople directed questions about the proposed $100 million ad campaign to PhRMA.
This month, drugmakers revived the “Harry and Louise” characters used to scuttle health legislation sought by the Clinton administration in the 1990s, this time to support current overhaul efforts. The television ads will run for three weeks and cost about $4 million. Families USA, a Washington- based nonprofit group, and PhRMA are paying for the commercials.