MedTech financial recovery is mixed

The financial performance of the American medical technology industry is experiencing the same kind of sluggish growth as the country’s economy in general. As reported in Medical Device Magazine’s “50 Companies to Watch”, the highest revenue reported by companies on the list was $921 million and the lowest was $750,000. In addition, many start-up companies–whose revenue isn’t made publicly available–also graced the list.

For start-up companies, competition for venture capital is more intense than ever. Figures from the MoneyTree report, produced by PricewaterhouseCoopers and the National Venture Capital Association, show a drop in investments in venture-backed U.S. companies in the first quarter of  2010.

Compared with Q4 2009, the medical device and equipment sector saw a 29% decline in dollars in Q1 2010, with $517 million invested in 61 deals. However, the Q1 2010 investments respresent an increase of 5.5% in dollars compared with Q1 2009. If 2010 investments trend like they did in 2009, investments will shoot up as the year progresses.

A survey conducted by MassMEDIC and PRTM, “MedTech Innovation in an Era of Change”, also shed some light on the financial health of the medical device industry. It surveyed 100 leaders from medtech companies and industry service providers that earned anywhere from $0 to >$1 billion in annual revenue.

A mixed response was found when respondents were asked how their companies performed during the current economic downturn. While 45% of respondants reported significant or slight growth, 14% reported a flat growth rate, and 41% reported a slight or significant decline. When comparing these results with the performance of the S&P companies, the survey concluded that “in general, the medtech industry has fared better than others.”

Based on its sample size, the survey also found that the type of medtech company played a factor in financial performance. Manufacturers of medical supplies and implantables were less affected by the weakened economy than the manufacturers of medical and diagnostic equipment. More than 40% of the respondents fomr diagnostic equipment manufacturers said that their companies has experienced a significant decline in 2009.

The survey revealed a potential silver lining for medical device companies going forward. When polled expanded health coverage would affect the maket size for their  company’ products, more about 41% said they expected some sort of increase. Only about 16% expected a decrease or significant decrease. 

With Health Canada recently banning plastic baby bottles made from bisphenol and proposing to ban certain toys, questions arise about whether similar actions should be taken to safeguard pregnant women.

Citing possible risks to young children, Health Canada recently banned plastic baby bottles made from bisphenol A and is proposing to ban toys containing six types of phthalates, best known as the rubber duck chemical.

Singling out babies and toddlers for special protection against harmful chemicals is a good idea because infants, with their rapidly growing bodies and unique exposure patterns, can be more vulnerable to dangerous chemicals than are most adults.

But a question has arisen about Health Canada's actions: If young children shouldn't come into contact with the two chemicals, what about pregnant women and their fetuses, which are even more susceptible to harmful compounds, especially those with hormonal impacts, like these man-made substances?

Bisphenol A is an estrogen mimic, meaning exposure gives an extra hit of the female hormone, while phthalates interfere with testosterone production, reducing levels of the crucial male hormone.

During fetal development, in particular, humans are extremely sensitive to sex hormones. Everything from genital development to brain organization is choreographed by specific levels of these hormones circulating in the womb at precise points in the pregnancy. If levels are skewed by synthetic chemicals, there is the risk of irreversible, life-long changes occurring.

“Pregnant women and the fetus are in fact the greatest target group for all of these chemicals,” says Frederick vom Saal, a professor at the University of Missouri and one of the leading researchers in the U.S. investigating bisphenol A, or BPA as it is also known.

Health Canada needs “to now take the next logical step” and consider wider restrictions on the chemicals to reduce exposures in pregnant women, contends Dr. vom Saal. The agency shouldn't assume “that by just targeting protections for newborns they've done enough.”

Although Health Canada took action against the two chemicals to protect children, the most provocative research on both compounds has been done on pregnant rodents and on their pups during early neonatal life, the period that corresponds to the last part of gestation in humans. Because conducting experiments on pregnant women would be unethical, these animal laboratory tests are designed to flag possible harmful effects on people.

Such experiments have found dramatic results, including enlarged prostates, skewed mammary ducts that in women would translate into increased breast cancer risk, and the feminization of male genitals.

Safeguards for pregnant women are needed, agrees another top researcher in the field, Shanna Swan, director of the Center for Reproductive Epidemiology at the University of Rochester's school of medicine, and an authority on phthalates. While children are sensitive to the chemicals, they're “not as sensitive as the fetus. There is no question about that,” says Dr. Swan.

Dr. Swan has published a study finding that women who have higher levels of phthalates during pregnancy give birth to boys with a slightly shorter distance from the start of their genitals to the anus, mirroring a discovery made in male rodents exposed to the chemical. In rodents, the shrinkage is viewed as feminizing the male genital tract, but the effect occurred at far higher doses than what is found in people exposed to the chemicals.

Nonetheless, because there is animal evidence of harm during gestation, Dr. Swan says “we should assume until proven otherwise that it's reproductively toxic to humans.”

Health Canada said it is monitoring research on the chemicals, but it believes the weight of evidence does not yet warrant measures to reduce exposures by pregnant women.

“Health Canada will take appropriate action if a risk to human health is identified,” it said in an e-mailed response to questions.

But the federal agency has begun several studies on pregnant women and their babies to see whether the animal research is onto something, and has ordered up research to see if the genitals of newborns have been affected by their mothers' exposure to the two chemicals.

Last month , for instance, it posted a notice indicating that it has asked a McMaster University researcher to study pregnant women to find out whether BPA affects the anogenital distance in their babies. It has a similar study on phthalates to try to duplicate Dr. Swan's findings.

In human babies, as in rodent pups, males typically have a larger distance from the anus to the genitals than females, and it is likely that anything reducing the sex difference would be hormonal in nature.

The chemical industry said it welcomes the research and predicted its products will get a clean bill of health. “We are confident that the levels of bisphenol A that will be found will be extremely low and we think it's unlikely that any health effects will be observed,” said Steven Hentges, spokesman for the American Chemistry Council.

The council also represents phthalate makers and has argued that the research showing effects on the genitals of boys is flawed.

It's been relatively easy for Health Canada to introduce measures restricting infant exposure to phthalates and BPA by ordering them out of just a few products such as plastic baby bottles and toys. If it decides pregnant women need protection, it faces a much harder task because products containing the substances are ubiquitous.

“The ability of governments to actually tackle adult exposures is going to be extremely challenging,” Dr. vom Saal predicted.

Pregnant women wanting to reduce their exposure while the government researches the issue may have difficulty because many plastic products don't disclose what they're made from, although some polycarbonates containing BPA carry the plastic industry's symbol of a triangle encasing the number seven, while polyvinyl chloride, which often contain phthalates, sometimes carries a triangle encasing the number three.

As well, there isn't a full understanding of how humans are being exposed to the chemicals, but residues in food from packaging and processing equipment are suspected. Some researchers believe other sources might be important, such as breathing dust containing the chemicals or absorbing them through the skin, as people would do for compounds in cosmetics.

The uterus doesn't offer protection against the compounds, which have been detected in the placenta, amniotic fluid and umbilical cord blood, indicating that maternal exposure leads to fetal exposure.

The amounts of exposure in people are low, but according to some experts, they are still worrisome. Blood concentrations of bisphenol A are typically a couple of parts per billion, while phthalates measured in urine can be thousands of parts per billion. One part per billion is a tiny amount, the equivalent of one second of elapsed time over nearly 32 years.

But Dr. vom Saal cautioned that these concentrations are far higher than the natural amounts of estrogen in people, which are in the parts per trillion, and testosterone, in the parts per billion. He says that because people's hormone systems are already operating at their natural levels, any alterations caused by phthalates and BPA should be a source of concern.

Health Canada studying effect of chemicals on infant genitals

Health Canada has quietly been studying a delicate topic: Whether or not the genitals of Canadian babies are being altered by their moms' exposure to bisphenol A or phthalates during pregnancy.

The research will measure the distance between the start of a baby's genitals and its anus, a space that on average is larger in boys than in girls. If the space is getting smaller, it means boys are being born less manly, and likely to have smaller penises and testicles.

The phthalate study is under way and will take up to five years to complete, while the bisphenol A research is just starting.

Phthalates, which are able to reduce levels of the male hormone, testosterone, are found in everything from polyvinyl chloride shower curtains to floor tiles, where they're used to make plastics less brittle. They're also added to cosmetics and perfumes to make the fragrance last longer.

Bisphenol A, an estrogen mimic, is the main ingredient in polycarbonate plastic products, including office water-cooler jugs, lenses for eyeglasses and the protective coatings on compact discs. It's also in the epoxy liners found on the inside of most food and beverage cans, and in some carbonless paper register receipts.

All BPA is made by humans and isn't found in nature, although there are some microbial sources of phthalates.

Scientists have known for years that dosing pregnant rodents with phthalates feminizes their male offspring, giving them female-like areolas and nipples, and smaller genital tracts. The amounts used to prompt the effects are far above what people are exposed to, but recently, researchers in the U.S. believe that they have detected slightly smaller genitals in boys born to mothers with higher-than-average phthalate exposure during pregnancy.

Bisphenol A has raised health concerns too, with tests in experimental animals leading to such conditions as early puberty, genital malformations and increased prostate growth, often at low doses given during fetal development.

The federal government is also testing several thousand Canadians for their BPA and phthalate levels, but the results are not yet available. Bio-monitoring in the U.S. has found that nearly everyone carries detectible amounts of the two chemicals. One survey conducted between 2003 and 2004 found about 93 per cent of Americans have bisphenol A in their bodies, and researchers looking for phthalates have found a similar percentage.
 

This text is based on an article by Martin Mittelstaedt. It appeared in the Life section of the Globe and Mail published on Thursday, Aug. 06, 2009

Cognitive problems following bypass surgery are not caused by the use of a heart-lung machine, or ‘pump,' researchers say

Is “pump head” syndrome for real?

That's the term used to describe the temporary memory loss, blurred vision and slurred speech that occurs in some patients who undergo a heart-bypass operation.

Some medical experts believe the mental confusion results from patients being hooked up to a heart-lung machine, which is used to pump blood and supply the body with oxygen while the heart is stopped during surgery. They think the machine, or so-called “pump,” somehow alters the blood so that brain functions are impaired for a prolonged period after surgery. One research team has raised concerns it may cause permanent brain damage.

But a new study suggests that pump head syndrome doesn't exist – or, at least, the heart-lung machine can't be blamed for any cognitive problems observed in patients following surgery.

Researchers at the Johns Hopkins University's school of medicine in Baltimore compared the mental state of patients who had surgery either on or off the pump.

That means some patients underwent standard heart-bypass surgery while connected to the pump. For the other patients, doctors performed a more complex procedure in which they operated on the heart while it continued to beat on its own, eliminating the need for the heart-lung machine.

(During heart bypass surgery, blood vessels removed from elsewhere in the body are grafted to the outside of the heart in order to supply the heart muscle with adequate blood flow to areas where existing arteries are blocked or restricted.)

According to the findings published in Annals of Thoracic Surgery, “there was no difference in the cognitive

outcomes between the two procedures, either in the

short term or the long term,” lead researcher Ola Selnes said.

That's not to say that some patients don't experience confusion immediately following surgery. After all, an operation can be stressful on the body and the mind.

However, Dr. Selnes said, “we're pretty confident the pump itself is probably not a major culprit.”

He added that certain patients may have other health problems – such as restricted blood vessels in the brain – that make them prone to feeling disoriented after a major operation. For the most part, though, the side effects are temporary.

The study “ought to reassure patients … and help remove some of the stigma from conventional bypass surgery,” Dr. Selnes said.

To this day, malaria remains one of the worst scourges of humankind. There are an estimated 500 million cases each year, resulting in more than one million deaths.

And it's not the only time a deadly human disease has been linked to chimps. HIV, which causes AIDS, is believe to have originated in these primates.

This text is based on a Globe and Mail article by Paul Taylor. It was published on Friday, Aug. 07, 2009.



Outrage in Canada as U.S. Firms Sever Ties To Obey Stimulus Rules

The Washington Post , Fri 15 May 2009  Page: A01 , Section: Asection  Byline: Anthony Faiola and Lori Montgomery

Is this what the first trade war of the global economic crisis looks like?

Ordered by Congress to "buy American" when spending money from the $787 billion stimulus package, the town of Peru, Ind., stunned its Canadian supplier by rejecting sewage pumps made outside of Toronto. After a Navy official spotted Canadian pipe fittings in a construction project at Camp Pendleton, Calif., they were hauled out of the ground and replaced with American versions. In recent weeks, other Canadian manufacturers doing business with U.S. state and local governments say they have been besieged with requests to sign affidavits pledging that they will only supply materials made in the USA.

Outrage spread in Canada, with the Toronto Star last week bemoaning "a plague of protectionist measures in the U.S." and Canadian companies openly fretting about having to shift jobs to the United States to meet made-in-the- USA requirements. This week, the Canadians fired back. A number of Ontario towns, with a collective population of nearly 500,000, retaliated with measures effectively barring U.S. companies from their municipal contracts -- the first shot in a larger campaign that could shut U.S. companies out of billions of dollars worth of Canadian projects.

This is not your father's trade war, a tit-for-tat over champagne or cheese. With countries worldwide desperately trying to keep and create jobs in the midst of a global recession, the spat between the United States and its normally friendly northern neighbor underscores what is emerging as the biggest threat to open commerce during the economic crisis.

Rather than merely raising taxes on imported goods -- acts that are subject to international treaties -- nations including the United States are finding creative ways to engage in protectionism through domestic policy decisions that are largely not governed by international law. Unlike a classic trade war, there is little chance of containment through, for example, arbitration at the World Trade Organization in Geneva. Additionally, such moves are more likely to have unintended consequences or even backfire on the stated desire to create domestic jobs.

Take, for instance, Duferco Farrell Corp., a Swiss-Russian partnership that took over a previously bankrupt U.S. steel plant near Pittsburgh in the 1990s and employed 600 people there. The new buy American provisions, the company said, are being so broadly interpreted that Duferco Farrell is on the verge of shutting down. Part of an increasingly global supply chain that seeks efficiencies by spreading production among multiple nations, it manufactures coils at its Pennsylvania plant using imported steel slabs that are generally not sold commercially in the United States. The partially foreign production process means the company's coils do not fit the current definition of made in the USA -- a designation that the stimulus law requires for thousands of public works projects across the nation.

In recent weeks, its largest client -- a steel pipemaker located one mile down the road -- notified Duferco Farrell that it would be canceling orders. Instead, the client is buying from companies with 100 percent U.S. production to meet the new stimulus regulations. Duferco has had to furlough 80 percent of its workforce. "You need to tell me how inhibiting business between two companies located one mile apart is going to save American jobs," said Bob Miller, Duferco Farrell's executive vice president. "I've got 600 United Steel Workers out there who are going to lose their jobs because of this. And you tell me this is good for America?"

The United States is not alone in throwing up domestic policies assailed by critics as protectionist. Britain and the Netherlands, for instance, are forcing banks receiving taxpayer bailouts to jump-start lending at home at the expense of overseas clients. French President Nicolas Sarkozy initially insisted that his nation's automakers move manufacturing jobs home in exchange for a government bailout, but backed down after outrage surged among his peers in the European Union, of which France is a central member.

But the number of measures, both proposed and enacted, from the Obama administration and Congress in recent months has raised an alarm among foreign governments, pundits and news media outlets. The buy American provisions in the stimulus package, signed into law in February, were just the beginning. Last week, Obama unveiled a series of proposals aimed at increasing taxes by nearly $200 billion over the next decade on U.S. companies doing business abroad. At a White House event, Obama said the measures were designed to "close corporate loopholes" that permit companies to "pay lower taxes if you create a job in Bangalore, India, than if you create one in Buffalo, N.Y."

A slew of legislative proposals is also aimed at keeping jobs at home. In recent weeks, the House attached additional buy American provisions to a $14 billion clean-water fund that provides loans to local communities and a $6 billion program to finance environmentally friendly school construction projects.  Other pending measures would require the federal government to buy 100,000 U. S.-made plug-in hybrid cars, mandate that the president's airplanes be made in the country by an U.S. company, and force several federal agencies, including the Pentagon and Department of Transportation, to use only domestic iron and steel.

Last month, Senate Majority Whip Richard J. Durbin (D-Ill.) introduced a measure with Sen. Charles E. Grassley (R-Iowa) to tighten rules governing the H- 1B visa program for guest workers. Among its provisions: Companies seeking to import specialized workers from abroad first must make a good-faith effort to recruit U.S. citizens. "The H-1B program was never meant to replace qualified American workers. It was meant to complement them because of a shortage of workers in specialized fields," Grassley said. "In tough economic times like we're seeing, it's even more important that we do everything possible to see that Americans are given every consideration when applying for jobs."

Buy American provisions are not new. Federal transportation projects have been required to use domestic iron and steel since 1982, and some defense contracts are limited to U.S. bidders. But the stimulus package marks the first time a buy American mandate has been broadly applied to projects across an array of federal agencies.

No one appears to be more concerned than America's largest trading partner -- Canada.

Initial concern north of the border over the buy American provisions died down after a clause, supported by the administration, was inserted in the bill clearly stating that the measure would not supersede existing U.S. trade obligations. During his Feb. 19 trip to Ottawa, Obama additionally pledged to avoid protectionism.

As passed, the act keeps that pledge, White House spokeswoman Jennifer Psaki said. "The president is committed to creating jobs in America and committed to global engagement with our trading partners and does not see any contradiction between those two goals," she said.

But in recent weeks as federal authorities drafted broad guidelines for implementing the law and hundreds of states and towns have begun preparing for stimulus-related projects, Canadian companies have been surprised to discover that while some federal contracts are still open to Canadian materials and equipment because of trade treaties, most of those issued by state and local governments are not.

The Government Accountability Office estimates that state or local officials will administer about $280 billion in stimulus spending, including about $50 billion for transportation projects. But federal authorities have determined that construction projects even partially funded with stimulus dollars must also buy American, dramatically increasing the universe of affected contracts.

As a result, John Hayward, president of Hayward Gordon, a Canadian manufacturer of pumps used in water works projects, says U.S. towns, including Peru, Ind., have told him that they can no longer buy his Canadian-made products.

"We're not China. We're not even Mexico. We have the same relative cost of labor as you do," he said. "If we have a better price, you should buy from us. That's what competition is supposed to be about."

To stay in business, Hayward is considering moving some manufacturing operations to the United States, potentially creating jobs here. That, Peru Mayor Jim Walker notes, is what the stimulus was supposed to be about.

"You're trying to get America turned around, trying to put Americans back to work," Walker said. "And if American taxpayers are paying for this, well then, Americans deserve the benefits."

© 2009 The Washington Post Company