December 8, 2023

Novelties: A Wearable Alert to Head Injuries in Sports

Head injuries can come from a single jarring impact during a game, or from a series of smaller jolts. But in the midst of play, many blows aren’t necessarily easy to spot by coaches, physicians or parents in attendance.

A crop of new lightweight devices that athletes can wear on the field may help people on sidelines keep better track of hits to players’ heads during games and practice sessions. The devices, packed with sensors and microprocessors, register a blow to a player’s skull and immediately signal the news by blinking brightly, or by sending a wireless alert.

Athletes can wear the devices pressed tightly to their heads, held in place by a headband within a beanie, for example, or even by an adhesive patch and Velcro.

Many of the systems are in research and development, but a few products are coming to the market this summer, including the CheckLight, a washable beanie created jointly by MC10 and Reebok. The beanie has an electronics module tucked inside it; a blow to the head sets off an LED readout on the outside. It starts blinking in yellow if the impact is moderate, or red if it is severe.

The CheckLight can be worn under a helmet for football or hockey, or by itself for soccer and other helmet-free sports. An MC10 spokeswoman said it would be available later this month at the Reebok Web site ($150).

Another sensor, the X-Patch from X2 Biosystems in Seattle, attached directly to a player’s head, sends data about hits wirelessly to the sidelines. The product will be out this fall, said Christoph Mack, X2’s C.E.O., who did not disclose the price.

Dr. Robert C. Cantu, a neurosurgery professor at the Boston University School of Medicine and medical director of the Sports Legacy Institute, which is seeking to prevent brain trauma in athletes, says he has looked into many of the new sensors as they have been developed. He’s in favor of them.

“They give you a rough estimate of total number of hits to the head the person has taken,” information of great importance to coaches, parents and athletes themselves, he said. “You don’t want to get a high number of hits,” he said, “because there is no hit that is good for your head.”

But the new devices shouldn’t be used to diagnose concussions, Dr. Cantu warned. “There’s no magic number you can read on a device that means you have a concussion,” he said. “Many more factors besides forces are involved.” Concussions can occur under a wide range of conditions, and no clear impact threshold has been established.

Stefan Duma, head of the Virginia Tech-Wake Forest School of Biomedical Engineering and Sciences, welcomed the new generation of sensors, particularly if they can be worn by women and by young players — both understudied populations in the world of contact sports and brain injury. “They may help us understand more about the risks that come with head impacts,” he said.

But he also had reservations about the devices, which he said could introduce a range of tricky problems. If a youth team on the field suddenly has several blinking lights, who will tend to the various players? What qualifications will the sidelines staff need?

Another issue could arise if opposing athletes see strategic possibilities in setting off the signals. “Players might target people and get their lights blinking to get them removed from the game,” he said.

The CheckLight was developed by Reebok, which makes the beanie, and MC10, a start-up in Cambridge, Mass., that is developing a line of flexible and stretchable electronics. Sensors in the cap — a tiny accelerometer and gyroscope — measure the head’s forward and twisting movements, said Steven Fastert, director of product development at MC10. An algorithm evaluates the impact, deciding if the hit is negligible, moderate or severe.

The sensor can be used for about 13 hours continuously and can be recharged with a USB cable. The total number of hits can be read when the battery is recharged.

In research projects, scientists have long used special football helmets with instruments embedded inside them to measure head impacts. Dr. Dumas of Virginia Tech, for example, has used such helmets in his research for 11 years with its football players.

“I’m glad to see more systems and technologies coming to expand measurement outside the helmet,” he said.


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F.D.A. Panels Back Sterner Language on Bone Drugs

But they stopped short of specifying what the safety warnings should say and did not recommend limiting use of the drugs to a proposed five years. About 11 percent of women 55 and older take the drugs to prevent bone fractures.

The medical advisers did not press the issue as strongly as the F.D.A. staff itself did in a 45-page report issued on Wednesday. The staff report said studies “suggest no significant advantage of continuing drug therapy beyond five years.”

The F.D.A. is expected to issue a revised label in November for the drugs, known as bisphosphonates, including Fosamax, Actonel and Boniva.

The agency usually follows the advice of its advisory panels, but not always.

The two panels met jointly on Friday to comment on the staff’s broad safety review of the drugs, prompted by concerns over a relatively small number of long-term users who had suffered unusual thigh fractures or a serious jaw disease. The benefits of the drugs have only been proven for three to five years, not longer, F.D.A. staff members said, warning about links to those rare conditions after longer use.

The advisory meeting ended in a 17-6 vote on a single question put to the panel for a vote: whether the labels should “further clarify the duration of use” of the drugs. Several advisers said the question was vague. So are the current labels, which say, “The optimal duration of use has not been determined.”

The F.D.A. said an estimated 9 percent of users take the drugs longer than three years, and under 1 percent take them longer than five years.

But none of the panel members recommended firm restrictions on longer-term use. None suggested a so-called black box warning, as some former patients who suffered the injuries are seeking.

Dr. Lewis S. Nelson, a toxicologist with the New York University School of Medicine, said the evidence warranted “something a little bit more dramatic,” like moving the statement to the “warnings” section of the label from the section on “indications and usage.”

Others said few patients heeded the label, anyway. They suggested stronger language asking doctors to review the usage annually.

Dr. Nelson is chairman of the F.D.A. Drug Safety and Risk Management Committee; it joined the Advisory Committee for Reproductive Health Drugs in the daylong review.

Dr. Clifford J. Rosen, a professor at the Tufts University School of Medicine, who voted for the new label, opposed a tougher warning for people to stop taking the drugs.

“I wouldn’t put a limit of five years for therapy because that would handcuff a lot of doctors,” he said.

Several advisers said the new label needed to be much more specific about benefits during the first three to five years and about the uncertainties after that. They said doctors and patients should consider a variety of factors while individually considering longer-term use of the drug.

The six people who voted against a label change said there was insufficient evidence of risk in longer use, especially with a drug proven to benefit women for the first three to five years.

“I don’t want to cry wolf on this,” said Dr. John M. Kittelson, a professor in the Department of Biostatistics and Informatics at the University of Colorado Denver.

Several women who have suffered the unusual fractures testified at the meeting.

Dr. Jennifer P. Schneider, whose thigh broke as she was standing in a New York subway, presented her own review of 111 cases.

Almost all took the drug for more than five years, most for a pre-osteoporosis condition called osteopenia, she said. Many felt pain in the thigh before the bone suddenly broke.

The first such drug, Fosamax, was marketed by Merck in 1995. Others include Actonel and Atelvia from Warner Chilcott and Boniva from Roche Therapeutics. Worldwide sales last year were $7.6 billion.

The committee also called for more study of the overall effectiveness of the drugs in their desired goal of preventing fractures. And the advisers recommended that the F.D.A. take a close look at why the drugs are prescribed as preventive medicine for women who do not even have osteoporosis.

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As Generics Near, Makers Tweak Erectile Drugs

Levitra, another erectile dysfunction drug, is now sold as a dissolvable tablet in nine European countries and may come to American pharmacies as soon as this month under the name Staxyn. That new form of the drug, which fizzes and dissolves in seconds, is marketed in a pocket-size, midnight-black box for men who prefer to take it discreetly, without water.

The third drug for erectile dysfunction to reach the market, Cialis, now eight years old, is racing ahead of the others because of two ideas that have proven extremely popular: an everyday pill and a 36-hour “weekender.” Cialis is projected to become the top-selling of the three drugs in the world this year, passing Viagra.

The market for drugs to correct erectile dysfunction has passed $5 billion a year from sales to tens of millions of men. And it is increasingly being driven by novel applications to compete with the lower-priced generics on the horizon.

“ ‘Gimmick’ is a strong word, but all of this is designed to create new brand identities,” Dr. Joseph P. Alukal, an assistant professor and director of reproductive health at the New York University School of Medicine, said. “A newer product, less expensive, and a new form of taking it — all that might convince more people to try it.”

Research is also under way in Brazil on a faster-acting form of the drugs, which increase blood flow by relaxing smooth muscle cells. While the existing pills enter the bloodstream indirectly by way of the stomach, intestines and liver, this form would enter more directly, dissolving in a capillary-rich space under the tongue and increasing the blood flow within 10 or 15 minutes. The research in Brazil involves generic Viagra, but Pfizer says it is not sponsoring the work.

The Mexican experiment with Viagra Jet will show whether the chewable form of the drug has promise in other countries, particularly developing markets, Susan O’Connor, Pfizer’s vice president of global commercial development, said in an interview. Studies showed most Mexican men who used Viagra ground it up to make it easier to swallow or in the belief it would start acting faster.

In explaining why the drug is being test-marketed in Mexico, Ms. O’Connor cited “patient preference, found in market research.” Mexico is the biggest market for Viagra in the developing world, with about $55 million in sales last year. At this point, Pfizer does not have plans to bring Viagra Jet to the United States, she said.

In America, Pfizer is battling to keep low-price generic competition off the shelves a year from now, when the drug’s patent expires. The generic pills would cost only a fraction of the $10 or more that each pill now costs.

Bayer, meanwhile, has introduced the dissolvable form of its Levitra drug in Austria, France, Hungary, Germany, Spain, Poland, Sweden, Denmark and Britain, where it went on sale in late March. The drug is called Levitra ODT, for orodispersible tablets. It comes in a thin black package the size of a half-dozen stacked credit cards, with four pills on a card that slides out.

“It’s pocket-friendly, discreet and gives the product a playful edge over its competitors,” Thomas Proske, global brand manager for Levitra at Bayer Healthcare, said in a statement.

The same pill was approved in the United States last June under the brand name Staxyn.

It will be available in pharmacies this month, according to Jess Macnaught, marketing executive with Burgopak Design and Packaging, the London company that designed the new black package. GlaxoSmithKline and Merck have licensed American rights from Bayer, but they declined to reveal when the drug would be introduced. Last year, they said Staxyn would reach the market in late 2010.

Worldwide sales of erectile dysfunction drugs grew 6.9 percent in 2010, to about $5 billion, and 4.7 percent in 2009, according to the industry data firm IMS Health.

Dr. Alukal of New York University said he thought Staxyn could be sold for a much lower price than what Levitra and other pills now cost, in part to compete with a generic Viagra. No price has been revealed.

“I guess it could be easier to ingest, so it could expand its market somewhat, but in the end the bigger issue would be cost,” Dr. Alukal said. He said the companies, for whom he does not consult, had talked about lower pricing, perhaps to under $10 a pill.

But for now, Pfizer, the company that started it all, is focusing its attention on protecting the pricing power and brand integrity of Viagra.

Patrick Ford, a former F.B.I. agent who leads the company’s security operations in the Americas, says Viagra is the most counterfeited product in the world. His agents pose as buyers, collect evidence and bring fraud cases to prosecutors, and he says fake Viagra may be unsafe. Pfizer and other pharmaceutical companies are working with Victoria Angelica Espinel, the government’s intellectual property enforcement coordinator, a position President Obama appointed her to in 2009.

Pfizer is also using its legal firepower against would-be generic competitors. Pfizer has two patents for Viagra, one for its chemical, expiring in 2012, and the other for its use against impotence, expiring in 2019. Pfizer sued Teva Pharmaceutical Industries, the biggest generic-drug company, in March 2010 under the “use” patent. The suit is pending in a Virginia federal court.

MacKay Jimeson, a Pfizer spokesman, said the company was confident it would keep the 2019 patent protection, but industry analysts disagree.

“ ‘Use’ patents are not highly probable of being upheld in court,” said C. Anthony Butler, a Barclays Capital pharmaceuticals analyst. “Most if not all analysts assume the expiry of the drug upon expiry of the composition of matter patent.”

The chemical patent expires on March 27, 2012. Pfizer may be able to extend it another six months, to September 2012, under a federal law called the Best Pharmaceuticals for Children Act. The law is meant to encourage drug companies to study children’s uses, often a difficult and unprofitable area.

In this case, what would be studied is not Viagra for children, but Revatio, a formulation of the same chemical, sildenafil, which is approved for pulmonary arterial hypertension, a rare and dangerous condition affecting hundreds of children in the United States. Mr. Jimeson said the company was working closely with the Food and Drug Administration to discuss the pediatric studies of Revatio and the potential for an extension on the chemical patent, which would also protect Viagra and its prices.

Many men, though, have waited years for a lower-priced Viagra and their wish may come true next year.

Other researchers are testing new uses for Viagra that Pfizer says it is not financing. Boston University is studying it with testosterone gel in men 40 to 70. Laboratório Teuto Brasileiro, in Brazil, where the patent expired last year, has filed a notice of intent to test it in a tablet that dissolves under the tongue and has an effect in 10 minutes or so. Pfizer owns 40 percent of the lab but says that it did not initiate the study.

Eli Lilly, meanwhile, says it has no plans to try chewable or dissolvable or any other forms of its Cialis tablets, and why should it? Cialis sales have steadily increased since it was introduced in 2003, to $1.7 billion last year, close to Viagra’s $1.9 billion. The health care investment house Leerink Swann estimates that Cialis sales will edge past Viagra in 2011 and far surpass the iconic blue pill in 2012.

Shawn Heffern, Lilly’s United States marketing director for Cialis, says, “I couldn’t be more happy.”

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