Overseas, Under the Knife
By ARNOLD MILSTEIN, MARK D. SMITH and JEROME P. KASSIRER
The New York Times, June 10, 2009 — ONE consequence of the high cost of medical care in the United States has been the rise of medical tourism. Every year, thousands of Americans undergo surgery in other countries because the allure of good care at half the price is too good to pass up.
Average total fees at well-regarded hospitals like Apollo and Wockhardt in India are 60 percent to 90 percent lower than those of the average American hospital, according to a 2007 study by the consulting group Mercer Health and Benefits (where Dr. Milstein is affiliated). Even compared with low-cost American hospitals, the offshore fees are 20 percent to 50 percent lower.
Most medical travelers seek cosmetic procedures like facelifts and liposuction, but an increasing number have high-risk operations like heart surgery and joint replacement in places like India, Singapore and Thailand.
Is this a good idea? The only way to know is to find out how foreign hospitals and surgeons compare with their American counterparts.
Which Americans consider this option? Typically, they are people who have either no health insurance or meager coverage. Though not poor enough to qualify for Medicaid, they cannot afford a good health plan. But lately, even some people with good coverage have been encouraged to take advantage of cost savings abroad.
A few pioneering American insurers like Blue Cross Blue Shield of South Carolina and self-insured employers like the Hannaford Brothers supermarket chain sent American doctors to evaluate foreign hospitals. Favorably impressed, they now offer payment for travel expenses and cash incentives as high as $10,000 for choosing offshore hospitals.
For very costly operations like open heart surgery or hip joint replacement, savings far exceed these payments. That is not to say that offshore surgery could substantially lower health care costs. Less than 2 percent of spending by American health insurers goes to the kind of non-urgent procedures that Americans seek overseas.
Other negatives are obvious: people having surgery done halfway around the world are far from their regular doctors as well as friends and family. Consider, also, what happens if an American abroad falls victim to negligent care. Arranging transfer to another hospital may be difficult – and malpractice suits typically face longer odds and smaller payments than in the United Sates. To mitigate these problems, some insurers and free-standing medical travel services offer coordination with American doctors, local concierge services and supplementary medical malpractice insurance.
There is reason to think the quality of care at some foreign hospitals may be comparable to quality in the United States. More than 200 offshore hospitals have been accredited by the Joint Commission International, an arm of the organization that accredits American hospitals. Many employ English-speaking surgeons who trained at Western medical schools and teaching hospitals.
So should offshore surgery be welcomed as a modest way to make American health care more affordable? We can’t know until we can directly compare the outcomes with those of American surgery. To begin, we must adopt a uniform way for American hospitals and surgeons to report on the frequency of short-term surgical complications.
Medicare could do this by requiring that all participating hospitals and surgeons count pre-surgical risk factors and post-surgical complications during hospitalization and for 30 days afterward, when most short-term problems become evident. The system used for many years by Veterans Affairs hospitals to reduce surgical complications is the best option for this, since it is available to all American doctors through the American College of Surgeons. So far, however, only a small minority of surgeons participate in this or any other valid national system of reporting surgical outcomes.
Patients and their surgeons also need comparable measurements of long-term success. Medicare should lead by adopting Sweden’s method of monitoring hip joint replacement outcomes. It tracks, for example, a patient’s ability to walk without pain six years after surgery.
Finally, Medicare should invite accredited offshore hospitals and their affiliated doctors to participate in all of its comparative performance reporting systems. Beyond informing Americans contemplating treatment abroad, such comparisons would allow us to learn if our care is the world’s best – and to accelerate our improvement efforts if it is not.
Arnold Milstein is a doctor specializing in health care improvement. Mark D. Smith is an internist and the chief executive of a health care foundation. Jerome P. Kassirer is a professor at Tufts University School of Medicine.
The New York Times, June 2009, by Reed Abelson — The insurance industry says it wholeheartedly embraces a health care overhaul, promising Congress and the president that it will make it much easier for individuals to buy insurance on their own.
Insurers, for example, have agreed to sell policies even to people with pre-existing medical conditions, and to stop basing prices on how healthy or sick someone is. These sweeping concessions would help legislators achieve their goal of putting health coverage within reach of many of the nearly 50 million individuals who currently have none.
But so far, the industry has made no such promises about another segment of the health insurance market, one responsible for many people being uninsured in the first place: the market for small employers. By some estimates, about half of the nation’s uninsured are people who are self-employed or work for a small business.
In other words, policy analysts and others say, unless the insurance industry is willing to give some of the same ground to small businesses that they have ceded to individual policy holders, a big part of what is wrong with the nation’s health care system may not get fixed.
More than 40 percent of the private American labor force works for companies with fewer than 100 workers. Leaving small businesses out of the federal effort to overhaul health care would be “a big hole in any reform proposal,” said Karen Davis, president of the Commonwealth Fund, a nonprofit health care research group that advocates significant changes to the current system.
Employer-provided medical insurance remains the bedrock of the nation’s health care system. And yet, while most big employers still provide health benefits, soaring premiums have meant many small businesses can no longer afford to cover their workers. But the small-employer market remains one of the most profitable segments of health insurance, which may be why the industry is not eager to overhaul this lucrative part of the business.
Lobbyists for small employers argue that Congress should be forcing the same concessions from insurers in the small-business market that the industry has promised in the individual market.
“For us, there is a huge issue in not only addressing just one of the broken markets, but two of those broken markets,” said Michelle Dimarob, a lobbyist for the National Federation of Independent Business, a trade association for small companies.
The insurance industry’s main trade association, meanwhile, is notably silent on the issue. And individual insurance companies seem divided.
Some large insurers, like Aetna and Cigna, say they would generally support similar federal rules for both the individual and small-business markets. “We need to be relatively consistent,” said H. Edward Hanway, Cigna’s chief executive.
But one of the biggest insurers, WellPoint, opposes changing the way coverage is sold to small employers.
“Those markets generally work today,” said Bradley M. Fluegel, the chief strategy officer for WellPoint, which is a big operator of Blue Cross plans and a major player in the small-business market. “They are well regulated by states today.”
Small employers do not necessarily agree.
“We face almost the same challenges as individuals,” said Michael Boucher, who runs his own landscape architecture firm in Freeport, Me. He provides coverage to more than a dozen people, paying $1,100 a month for a worker with family coverage.
Much of the Congressional talk about health care has not yet focused on what federal oversight, if any, might be necessary for the small-business market. Proposals before the Senate Finance Committee seem to envision the same kind of rules for both the individual and small-business markets. And some House members seem to lean in that direction, too.
“For small businesses already under enormous financial strain, rising health care costs simply add more pressure,” said Representative Nydia M. Velázquez, a New York Democrat who heads the House committee on small business and plans to hold hearings on the topic on Wednesday. “Meaningful health care reform will need to include small-group market reform.”
She favors giving small employers additional tax credits for offering health benefits, and letting them form purchasing pools to obtain cheaper coverage from insurers.
What Congress finally comes up with, of course, is still anyone’s guess.
Unlike large companies, which tend to self-insure and can spread medical risks over a large work force, small businesses typically rely on an insurer to help assume that risk. And they buy that insurance much the same way individuals currently do, in a market overseen by a patchwork of state regulations.
So small employers are at the mercy of the same practices that make it hard for individuals to obtain coverage – like insurers’ trying to avoid covering older people or ones likely to run up high medical bills, and charging high prices for the policies they do offer.
“We struggle every year to find a way to make it work,” one small-business owner, Kelly Conklin, said at a Congressional hearing in late April.
Mr. Conklin’s woodworking company, Foley-Waite Associates, in Bloomfield, N.J., paid premiums of about $4,600 a month last year to cover 13 employees. Foley-Waite picks up about three-quarters of that amount.
When his insurer said this year that it would raise the premiums to about $6,000 a month, he was forced to switch carriers, finding another policy for about $4,800 a month.
The current system is “designed to be expensive,” Mr. Conklin said.
As a result, fewer small businesses are offering coverage – especially the very smallest employers. About half of companies with nine or fewer workers do not provide health benefits.
WellPoint says the health care answer for the smallest businesses might be to group them with people who buy coverage in the individual market.
The UnitedHealth Group, by some measures the nation’s largest health insurer, agrees that the very smallest businesses should operate under the same rules now being proposed for individuals. But the company declined to discuss whether it would favor changes for somewhat larger employers, in the absence of a specific proposal in Washington for handling small-business insurance.
Under the current system, individual states determine how much more an insurer can charge one small business than another, based on the relative health of each work force. And it is the state that determines how much an insurer can raise rates from one year to the next.
“There is a lot of variation across states,” said Gary Claxton, an insurance expert at the Kaiser Family Foundation. He also noted that many states lack the resources necessary to actively enforce their rules.
Other insurers that have not embraced changes are ones that, like WellPoint, operate Blue Cross plans, which tend to be the largest players in a state’s small-business market. The Health Care Service Corporation, a Blue Cross operator in big states including Texas and Illinois, would not discuss its position on the issue. The national association representing Blue Cross plans also declined to comment.
Mr. Fluegel, the WellPoint executive, warned that if the federal government intervened in the small-business market so that insurance companies could no longer assign the highest premiums to employers with the highest medical costs, insurers would be forced to spread the costs over all their small-business customers. That could mean some small employers would end up paying more for coverage than they do today, he said.
But Ms. Dimarob, of the independent business federation, says the small-business market even now is “dysfunctional,” which is why she argues that the federal government needs to step in and work with the states to remake the market.
“If you truly want to build off the strength of the employer-based system and want comprehensive health reform and access to quality affordable health care,” she said, “why would you only fix the individual market?”
The New York Times, June 10, 2009, by Donald G. McNeil Jr — The swine flu virus is rapidly making its way around the world, but it has been relatively mild so far, causing only 139 confirmed deaths. Could it mutate into something more lethal?
Scientists looking at its genetic structure say there is no obvious pressure for it to do so – no reason for this virus to “want,” in the Darwinian sense, to kill more of its hosts.
It is already doing a near-perfect job of keeping itself alive by invading human noses and inducing humans to cough it from one to another, said Dr. W. Ian Lipkin, director of the Center for Infection and Immunology at Columbia University‘s Mailman School of Public Health.
“A really aggressive flu that quickly kills its host” – like SARS and H5N1 avian flu – “gives itself a problem,” Dr. Lipkin said.
But flu viruses are highly mutable, and anything could happen in the next two years, the time a new strain normally takes to circle the globe. After all, Spanish influenza began as a mild strain, then turned horrifically virulent, killing 20 million to 100 million people in 1918-19.
But Dr. Peter Palese, head of microbiology at Mount Sinai Medical School and part of the team that rebuilt that virus in 2005 from fragments found in old lung tissue, said that strain was a “once-a-millennium or once-every-10-millennia event – things like it don’t happen very often.”
Nor is it clear, he added, that viruses really “want” a particular outcome.
“For me, that’s too much anthropomorphic thinking,” Dr. Palese said. “Look, I believe in Darwin. Yes, the fittest virus survives. But it’s not clear what the ultimate selection parameter is.”
A mutation that confers lethality, he explained, may confer another advantage scientists have not pinned down.
The new virus has been described as “a real mutt” by Walter R. Dowdle, the former chief of virology for the Centers for Disease Control and Prevention, because of its unique mix of Eurasian and American swine, human and bird genes.
Flu chromosomes are quite simple – eight short strands of RNA that issue the genetic code for a grand total of 11 proteins. They break apart in a jumble inside cells they infect, and then they reassemble, picking up random bits of other flus, which makes the results unpredictable.
The current swine flu strain lacks several genes believed to increase lethality, including those that code for two proteins known as PB1-F2 and NS-1, and one that codes for a tongue-twister called the polybasic hemagglutinin cleavage site.
PB1-F2 appears to weaken the protective membrane of the energy-producing mitochondria in an infected cell, ultimately killing the cell. Specifically, it attacks dendritic cells, the sentinels of the immune system. Its lethality could be accidental – a protein good at killing sentries might just go on killing other cells once inside the fort.
All pandemic flus, including those of the Spanish, Hong Kong and Asian flus, make PB1-F2. So does the H5N1 bird flu. The current swine strain does not.
The NS-1 protein also maims the immune response by blocking interferon, an antiviral protein made by cells.
Very lethal bird flus also have the unusual cleavage site, which allows the hemagglutinin spike on the virus’s shell to split and inject its genetic instructions into different kinds of cells, like those in the lungs and the gut.
Such an addition to the novel H1N1 would be very dangerous. But because it has been found only in avian flus, it is unlikely to become a component of a human flu, Dr. Palese said. Even the 1918 virus, which was avian in origin, lacked it.
A much more likely change, scientists have said, is that the H1N1 swine flu will become resistant to the antiviral drug Tamiflu. A gene for Tamiflu resistance is now almost universal in seasonal H1N1 flus.
If that happens, the world’s Tamiflu stockpiles will be all but worthless, and doctors may have to switch to Relenza, which is a powder used with an inhaler, which makes it more expensive and harder to take.
Depending on the mutation, older antiviral drugs like rimantidine may be useful, but so much resistance to them developed in seasonal flu that they were largely abandoned a few years ago.
Dr. Palese was asked about another notion concerning likely mutations. There has been outrage at Egypt’s decision to kill all the pigs belonging to its Coptic Christian minority. It has been depicted as misguided and motivated by religious bigotry, because the “swine flu” is really now a human flu.
But Egypt is also in an especially dangerous situation. The new swine flu reached it just last week. The H5N1 avian flu has circulated in its backyard chickens since 2006, defying all eradication efforts. In the last year, dozens of H5N1 cases have been confirmed in toddlers, almost all of whom have survived – which led some experts to speculate that those are cases of a less lethal version of H5N1 that is better adapted to humans.
In that case, might it be wise to get rid of the country’s relatively small pig population, since pigs are “mixing vessels” that can catch both human and bird flus?
“I agree with the premise, if you really could eliminate an animal reservoir,” Dr. Palese said. “But the virus is out of pigs now – and it’s more important that those poor people have something to eat.”
The New York Times, June 10, 2009, by Lawrence K. Altman MD — After decades of warnings about the inevitability of another pandemic of influenza, it is astonishing that health officials have failed to make clear to the public, even to many colleagues, what they mean by the word pandemic.
Generations of people have used the term to describe widespread epidemics of influenza, cholera and other diseases. But as the new H1N1 swine influenza virus spreads from continent to continent, it is clear that a useful definition is far more complicated and elusive than officials had thought.
And what is at stake is far more than an exercise in semantics. A clear understanding of the term is central to the World Health Organization‘s six-level staging system for declaring a pandemic, which in turn informs countries when to set their control efforts in motion.
Dictionaries and medical journals offer little guidance. Their definitions can be too vague or too narrow, contradictory and clouded by jargon.
“There is a lot of misinformation in the medical literature, and it is really quite hard to figure out what is and what is not a pandemic,” said Dr. David M. Morens, an epidemiologist at the National Institute of Allergy and Infectious Diseases who has been studying the history of pandemics.
The word implies the rapid spread of an infectious disease to many countries in different regions, hitting each with more or less the same severity. But in fact, severity varies – not all people are infected at the same time, and not every country need be affected.
And there can be many other factors, including the numbers and percentages of people falling ill and dying; a population’s vulnerability to the disease, based on previous rates of infection; and the quality of health care facilities and disease monitoring systems.
Not least is that scientists do not know precisely how pandemics arise, what fuels them, why they vary in their lethality, why some occur in waves and why they stop.
Health officials have long preached that with influenza, the only sure bet is to expect the unexpected. The new swine influenza virus, which appeared suddenly after years of warning about a potential pandemic of avian influenza, upset the W.H.O.’s assumptions that most people have the same understanding of the word pandemic.
For years, the organization’s Web site defined an influenza pandemic as causing “enormous numbers of deaths and illness.” But the agency recently pulled the definition, apologizing for causing confusion and anxiety.
One of the biggest problems in public health is communicating risk assessment.
United States and W.H.O. officials say their preparedness plans are intended for governments, not people in the street. Officials bristle at criticism that their messages and plans have led the public to equate the word pandemic with the Spanish influenza of 1918-19, the worst recorded pandemic in history, killing 20 million to 100 million people.
In preparing for the worst, officials have considered milder pandemics, said Dr. Nancy J. Cox, chief of the influenza division at the Centers for Disease Control and Prevention in Atlanta.
“We ought to be able to do a better job in communicating in an understandable way,” he said in an interview.
Scientists like to assert that theirs is an exact discipline. But like the terms “evidence -based medicine” and “peer review,” pandemic turns out to be another example of imprecise vocabulary that doctors use every day, assuming everyone understands their meaning.
Journals, textbooks and reference works use pandemic in discussing certain diseases, but rarely define the word.
For example, the definition section of the Control of Communicable Diseases Manual, a standard reference work, includes “endemic” (said of a disease that is usually present in an area or a population group) and “epidemic” (more cases of an illness than would normally be expected) but not “pandemic.”
The disease manual’s editor, Dr. David L. Heymann, a retired assistant director-general of the W.H.O., said the term had not caused confusion in the past, but assured me in an interview that “pandemic will be defined in the next edition.”
Even the indexes of most major medical textbooks do not list pandemic. One is Harrison’s Principles of Internal Medicine, of which Dr. Anthony S. Fauci, who directs the National Institute of Allergy and Infectious Diseases, is a main editor.
“It’s a mistake, and I’m surprised it’s not there because it should have been,” Dr. Fauci said in an interview.
Government agencies do not have official lists of pandemics. Textbooks cite many recent and old ones, including these:
¶AIDS. Many experts have called H.I.V. a pandemic. Others disagree, saying the virus is pandemic only in Africa.
¶Cholera. Since 1817, most experts agree, the world has had seven pandemics of this bacterial illness, which causes severe diarrhea and dehydration. ¶Acute hemorrhagic conjunctivitis. Beginning in 1969, an enterovirus has caused tens of millions of cases of a highly contagious, acute, painful, but rarely blinding, form of hemorrhagic eye inflammation.
¶Dengue. Since World War II, this mosquito-borne viral disease has spread widely in Asia and Latin America.
¶Syphilis. A pandemic of the bacterial disease raced through Europe and Asia after Columbus’s return from America and during mass movements of armies in Europe.
Although pandemics have been classically limited to infectious diseases, the term has spread to noninfectious, chronic ones. For example, many health officials now speak of pandemics of obesity and heart disease.
Knowledge about past pandemics is necessarily incomplete; historical accounts cannot make up for the absence of modern disease monitoring and laboratory tests.
About 14 pandemics of influenza have been described since the 16th century, with the first indisputable one occurring in 1889.
In 1580, an influenza pandemic swept through Asia into Europe within six weeks, and at least 10 percent of Rome’s 81,000 residents died in the first week, said Dr. Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. Some Spanish cities were almost totally depopulated.
Dr. Morens, of the infectious diseases institute, said his studies of influenza pandemics left a confusing track record and “are rewiring our brains about thinking about influenza.”
“The medical literature will tell you there were three pandemics in the 1830s,” he said – “one from 1830 to 1832, a second in 1833 to 1834 and a third in 1836 to 1837. But I am beginning to think they were all one pandemic.”
Dr. Morens said he was puzzled as to why no influenza pandemics were recorded for nearly 150 years after the one in 1580, although there were some severe localized epidemics.
“A period of pandemic stability makes us wonder whether a pandemic comes at any time by chance,” he said, “or whether something about epidemic situations prevents pandemics,” or at least delays them.
The W.H.O.’s staging system has long been part of its plan for an influenza pandemic. Deep concern about a potential pandemic of the H5N1 avian influenza virus led the organization to convene a large meeting of experts in 2005. Among other things, the experts recommended simplifying the staging system.
A number of doctors ask why health agencies do not declare seasonal influenza a pandemic when it spreads around the world.
But Dr. Osterholm, the Minnesota expert, said that “you can’t use the terminology for just worldwide transmission, because if you did that, you would say every seasonal flu year is a pandemic.”
“To me,” he continued, “a pandemic is basically a new or novel agent emerging with worldwide transmission.”
Dr. Keiji Fukuda, an influenza expert who is an assistant director-general at the W.H.O., said in an interview that “as difficult as things are right now,” the problem of defining a pandemic and communicating risk “would be magnitudes worse and more confusing” if the agency had not dealt with AIDS, SARS and avian influenza.
Those experiences prompted new international health regulations and pandemic plans, and allowed critical scientific information to be disseminated quickly, he said.
The process was “painful, sure,” he said. “But you can’t really do anything like this without having some amount of pain.”
GoogleNews.com, TheAustralian.com.au, June 10, 2009, by Tim Boreham — In the 1970s, scientists promised to rebuild crippled astronaut Steve Austin — the Six Million Dollar Man — with metal parts to make him “better, stronger, faster”.
Three decades later, we’ve got plastic hearts and limbs (with inflation adding a nought or two to the $6million bill). Otherwise, the bionic man concept is becoming redundant as regenerative medicine gains pace. Regrowing human cells is no longer the realm of science fiction, and investors can get a slice of the action.
Avita Medical (AVH) is a standout example of the potential of regrowing human cells, in this case to treat burns. Avita was created to commercialize its intellectual property (known as ReCell), famously devised by burns surgeon and Australian of the Year Fiona Wood. We’re oversimplifying things a tad here, but the surgeon simply sprays the cell-infused liquid on the affected area and new skin sprouts within seven days.
“Regenerative medicine is booming,” says Avita chief Bill Dolphin. “It will change the face of medicine and we are early in the process of getting these changes initiated.”
Avita last month won a $US1.45 million ($1.77million) grant from the US Armed Forces Institute of Regenerative Medicine to accelerate development of its cell-harvesting device. Sadly, the military will always churn out a steady supply of burns victims, so getting a few bucks out of AFIRM is not to be sneezed at. But the grant, won in the face of 25 rival submissions, has wider significance.
According to Dolphin, the AFIRM grant hopefully will expedite crucial approval by the US Food and Drug Administration. FDA assent means Avita can market to US burns surgeons, with an eager eye on the much larger cosmetic surgery market. The AFIRM-funded trials will take place mainly at military hospitals. But it’s easy to see the appeal to the military of the compact ReCell kits, which can be sent to remote field hospitals.
Lest we get carried away about the new frontiers rhetoric, it’s worth noting that ReCell already has European (CE mark) approval and has been sold there for years. Last year’s sales? A mere $50,000. Avita blames the distributors, who were poorly trained and acted as “order takers and delivery boys”. A push to win over the Continent’s medical opinion leaders has produced results, with expected sales this year of $500,000.
The result of the 2007 merger of Clinical Cell and Visiomed, Avita has had a tortured history and still has a modest market cap of $11.6 million. “We have been in the sin bin and are now getting out of the sin bin,” Dolphin says.
Interestingly, Avita has been shooting the breeze with Tissue Therapies (TIS), the idea being to strike a collaboration deal. “Of course I’m open to talking to everyone,” Dolphin says.
Given Tissue Therapies is developing cell treatment for wound healing, including chronic ulcers and burns, there’s an obvious symbiosis.
In April Tissue reported “excellent clinical results” in Canada relating to its VitroGro treatment for diabetic, venous and pressure ulcers. After six weeks of treatment, the second patient in the trial showed a 32 per cent reduction in the size of a chronic diabetic ulcer on the left heel. The first patient showed a 29 per cent reduction.
“This is an impressive result considering the patients had significant complicating clinical factors, including severe diabetes and kidney failure,” according to ABN AMRO Morgans. “The clinical trial of VitroGro is continuing on schedule and is expected to complete recruitment of up to 30 patients with three types of ulcers by mid-2009.”
After a $1.87 million rights raising, Tissue reports enough cash for the rest of the year. It then has to sniff out more cash or a tissue, a tissue, investors all fall down.
But as with Avita, Tissue makes for a better, stronger investment than your average biotech bear.
GoogleNews.com, WallStreetJournal.com, June 10, 2009, by Jared A. Favole — NEW ORLEANS (Dow Jones)–By nearly every measure, it has been a successful weekend for a new wave of proposed drugs that doctors are hailing as the most promising medicines for the millions of patients suffering from Type 2 diabetes.
Studies released at this weekend’s American Diabetes Association conference show proposed drugs from Novo Nordisk (NVO), Eli Lilly & Co. (LLY), Amylin Pharmaceuticals Inc. (AMLN), Alkermes Inc. (ALKS), and GlaxoSmithKline Plc (GSK) are better at helping Type 2 diabetes patients control their blood sugar and lose weight than most medicines currently on the market.
The drugs, referred to as GLP-1s, or “GLiPs” in industry jargon, also provide one benefit no other Type 2 diabetes medicines can: Patients need to take them just once a day or once weekly, as opposed to multiple times daily, a convenience factor doctors hail as extremely important for patients who often times forget, or neglect, to take treatments.
“The biggest problem we have in diabetes is adherence” to treatment schedules, Dr. John Buse said. Buse, a professor of medicine at the University of North Carolina, Chapel Hill, reviewed a study sponsored by Novo Nordisk about its proposed once-daily medicine, liraglutide. He has also consulted with many major pharmaceutical companies.
He said these new drugs are clearly “more powerful” than those taken multiple times a day, such as Byetta, marketed by Eli Lilly and Amylin.
“I think they are the most promising agents that we’ve seen yet for dramatically improving the health of people with Type 2 diabetes,” he said.
Dr. Richard Kahn, chief scientific and medical officer of ADA, echoed those sentiments. “This is an exciting class of drugs that has great potential,” he said.
Studies show they help Type 2 diabetes patients lose as much weight, though usually more, than current treatments. For instance, a two-year study involving Novo’s liraglutide showed patients taking the drug lost an average of six pounds, while those taking Amaryl, by Sanofi-Aventis SA (SNY), gained about 2 pounds. In a separate study involving a once-a-week version of Byetta, patients lost an average of 5.8 pounds. Companies funded both studies.
One catch: Federal regulators haven’t approved any of these drugs yet. Byetta, injected twice a day, has been on the market since June 2005 but the weekly version, called exenatide once weekly, is awaiting approval.
Novo’s liraglutide appears to be the most ripe for approval. A European medicines commission has recommended the treatment be approved. European regulators rarely go against the medicines commission’s recommendation.
Also, the drug appeared before a U.S. Food and Drug Administration panel in April, a key meeting for new drugs. The panel, composed of medical experts, was split on whether to recommend approval amid concerns the drug may be linked to a rare, but potentially serious type of thyroid cancer. Data Novo submitted to the FDA showed rodents tested with liraglutide grew tumors, which isn’t uncommon in rats. The panel and the FDA, however, said it wasn’t clear that the data from the rodents is relevant to humans.
Buse said it’s “unlikely” the thyroid cancer concerns seen in rats treated with liraglutide will affect humans.
The timing of the new treatments also appears serendipitous. A popular class of diabetes drugs called TZDs, which include GlaxoSmithKline’s Avandia and Takeda Pharmaceutical Co.’s (4502.TO) Actos, are coming under increased scrutiny amid concerns they are linked to increased heart risks.
GoogleNews.com, WashingtonPost.com, June 9, 2009 — Nearly two years after the Food and Drug Administration issued a formal advisory urging parents not to give over-the-counter cough and cold medicines to infants younger than 2 years old without a doctor’s advice, a study says many parents are still willing to give them to children as young as 13 months.
A major reason: misleading labels that use the word “infant” and display graphics of teddy bears, small children and similar symbols.
“It’s a wake-up call to those of us who work daily to provide health care to children, and to the public-health and pharmacy communities,” said Lee Sanders, an associate professor of pediatrics at the University of Miami Miller School of Medicine. He co-authored the study with researchers from University of Wisconsin, Vanderbilt University and others.
The researchers interviewed 182 parents and other caregivers of children 1 and younger. They asked them about their use of four common over-the-counter cough and cold medications whose labels warn not to use them in children younger than 2 without a doctor’s advice.
They found that 86 percent of the time, the caregivers misunderstood the labels and thought the products were okay to use in children younger than 2. More than half the caregivers said they would give the medicines to a 13-month-old child.
The study does not name the manufacturers of the drugs reviewed by the caregivers, Sanders said, because the medicines no longer are on drugstore shelves. But he urged the FDA, the Federal Trade Commission and other government agencies to pass new restrictions on such labels.
“This is true across the industry,” he said. “We would like to see the rules standardized.”
He also urged parents to be more careful in reading labels on over-the-counter medicines.