Sacramento, Jul 30 (AP/UNB) — Three pharmaceutical companies collectively are agreeing to pay California nearly $70 million to settle allegations that they delayed drugs to keep prices high, California Attorney General Xavier Becerra said Monday.
The bulk of the money will come from Teva Pharmaceutical Industries Ltd. and its affiliates for paying to delay a generic narcolepsy drug, Provigil, from entering the market for nearly six years.
Teva is paying $69 million, which Becerra says is the largest pay-for-delay settlement received by any state.
Such agreements let the developer of brand name drugs keep their monopolies over the drugs after their patents expire, thereby letting them continue to charge consumers higher prices. The drug developer pays the generic manufacturer to keep the cheaper version of the drug from entering the marketplace for an agreed period of time.
Teva said the money will come from a pre-existing fund that was created in 2015 as part of the company's settlement with the U.S. Federal Trade Commission over similar claims, and it will not make any additional payments.
Becerra said such agreements can force consumers and the health care market to pay as much as 90% more than if there were generic alternatives. More than $25 million of the settlement will go to a consumer fund for California residents who purchased Provigil, Nuvigil or Modafinil between 2006 and 2012.
"No one in America should be forced to skip or ration doses of medicine that they need ... and certainly not because a drug company is colluding to keep the price of your drug artificially high even when cheaper options could be available. But that's what's happening," Becerra said.
The second, $760,000 settlement is with Teva, Endo Pharmaceuticals and Teikoku Pharma USA over keeping a genetic alternative to the pain patch Lidoderm from entering the market for nearly two years.
Teva said it is paying $200,000 to cover the state's legal costs after settling similar federal claims earlier this year. Neither Endo nor Teikoku responded to requests for comment.
Both settlements bar the companies from pay-for-delay agreements for several years. Teva is agreeing to not to enter any such agreements for 10 years, while Endo Pharmaceuticals has an eight-year agreement and Teikoku a 20-year injunction.
Teva said the restriction is identical to its federal consent decree.
Becerra also backed pending legislation, AB824 by Democratic Assemblyman Jim Wood of Santa Rosa, that would ban such agreements.
The measure would require pharmaceutical companies to prove that their agreements are not anticompetitive. It passed the Assembly 56-0 in May and is awaiting a vote in the Senate.
Pharmaceutical companies oppose the bill, arguing the Federal Trade Commission already does this monitoring.
Dhaka, Jul 27 (UNB) - Doug Lindsay was 21 and starting his senior year at Rockhurst University, a Jesuit college in Kansas City, Missouri, when his world imploded.
After his first day of classes, the biology major collapsed at home on the dining room table, the room spinning around him, reports CNN.
It was 1999. The symptoms soon became intense and untreatable. His heart would race, he felt weak and he frequently got dizzy. Lindsay could walk only about 50 feet at a time and couldn't stand for more than a few minutes.
"Even lying on the floor didn't feel like it was low enough," he said.
The former high school track athlete had dreamed of becoming a biochemistry professor or maybe a writer for "The Simpsons."
Instead, he would spend the next 11 years mostly confined to a hospital bed in his living room in St. Louis, hamstrung by a mysterious ailment.
Doctors were baffled. Treatments didn't help. And Lindsay eventually realized that if he wanted his life back, he would have to do it himself.
Today Lindsay tells his remarkable story to audiences around the country, including at a TEDx event in St. Louis.
His journey since has amazed medical professionals.
"He did something extraordinary," said John Novack, spokesman for Inspire, a healthcare social network for rare and chronic-disease patients. When people hear Lindsay's story, Novack said, they often say, "I can do something similar for my kid."
His mother was a living prophecy
Whatever was wrong with him ran in the family.
By the time Lindsay was 18 months old, his mother was so weak she could no longer pick him up.
By the time he was 4 she could no longer walk. She did manage to pick him up one more time that year, when he was choking on a jawbreaker. She saved his life.
Otherwise, she was too frail. She lived for decades, mostly bedridden with the same condition that stole her son's twenties. After years of tests, she determined her condition was related to her thyroid, but she was too sick to travel to the Mayo Clinic to get more specialized care, Lindsay said.
Lindsay's aunt also developed the same ailment, growing so feeble she couldn't tie her own shoes.
As a teenager, watching his family members sidelined from life, Lindsay wondered whether his body was a ticking time bomb, too.
Finally, that day in 1999, the alarm went off.
"When I called my mom that night to tell her I needed to drop out (of college), we both knew," he said. The family curse had struck.
He found answers in discarded medical textbooks
From the fall of 1999 onward, Lindsay was bedridden about 22 hours a day.
"If I was up, it was because I was eating or going to the bathroom," he said.
Lindsay immersed himself in medical research, determined to find a way out. He saw specialists from endocrinology, neurology, internal medicine and other specialties. When one doctor was out of ideas, he referred Lindsay to a psychiatrist.
That's when Lindsay he realized he'd have to figure his predicament out on his own.
While in college he had picked up a 2,200-page endocrinology textbook near a garbage can, hoping to use it to figure out what condition his mom had. In it, he found an important passage discussing how adrenal disorders could mirror thyroid disorders.
By the time he was 19, Lindsay was almost completely bedridden
He zeroed in on his adrenal glands, which sit atop the kidneys on either side of the lower abdomen.
Using a stash of aging medical textbooks, Lindsay hypothesized that a whole class of autonomic nervous-system disorders could exist beyond the established categories of what most endocrinologists or neurologists knew about.
He cobbled together cash for a computer, had an old college roommate bring it over, and got to work.
Lindsay soon stumbled on the website for the National Dysautonomic Research Foundation, delighted that an entire organization was dedicated to researching the type of disorder plaguing him and his family. He asked the foundation to send him literature about emerging research in the field.
None of the diseases the foundation was examining fit Lindsay's pattern of symptoms. But he was getting closer.
He convinced a researcher who believed in him
Lindsay soon decided he needed a partner -- not just a physician but a scientist curious enough to take on a rare case and spend long hours with him parsing it out.
The best place to find that person, he reasoned, was at the American Autonomic Society's annual conference, attended by scientists from around the world who focused on nervous system disorders.
In 2002, he give a presentation about his disease at the group's meeting in Hilton Head, South Carolina. To get there, Lindsay bought a row of airline tickets so that, with the help of friends, he could lay across several seats during the flight.
At a research conference, Lindsay tried to convince specialists he had a disease that didn't appear in their textbooks
Lindsay arrived at the conference in a wheelchair, wearing a suit and tie, and presented himself as a Jesuit-trained scientist. He tried to comport himself like a grad student or a junior colleague to the scholars in the audience, not like a patient.
He was just a scientist living an experiment in his own body. During his talk, Lindsay argued that a certain drug might help him.
Several of the scientists disagreed with Lindsay's hypotheses about his ailment. But that wasn't unexpected. He didn't even have a bachelor's degree and he was telling doctors from Harvard University, the National Institutes of Health and the Cleveland Clinic something their medical training told them was impossible.
"They didn't patronize me. They treated me like a scientist," Lindsay said. "I was entering into a world of science I couldn't participate in because I was at home and couldn't be a grad student."
Dr. H. Cecil Coghlan, a medical professor at the University of Alabama-Birmingham, approached Lindsay after his presentation. Coghlan said he thought Lindsay was on to something.
At last, Lindsay had a medical ally.
His first innovation was repurposing a drug
In early 2004, one of Lindsay's friends rented an SUV, loaded a mattress in the back and drove him, lying flat, 500 miles to Birmingham.
Lindsay suspected his body was producing too much adrenaline. He knew of a drug called Levophed, which is approved by the US Food and Drug Administration to raise blood pressure in some critically ill patients. Levophed is basically an injection of noradrenaline, which counters the symptoms created by excess adrenaline.
It hadn't been done before, but Lindsay convinced Coghlan to repurpose the drug so he could live on a 24/7 noradrenaline drip for the next six years.
Lindsay spent "every second of every day" hooked up to an IV. It stabilized his condition and allowed him to be active for short periods of time around the house.
"I was no longer at risk of losing everything," Lindsay said.
Lindsay's unique case caught the eye of Dr. Cecil Coghlan, who specialized in treating dysautonomia disorders
Still, other than doctors' visits, a high school reunion and a few weddings, Lindsay's autonomic dysfunction kept him mostly confined to the house he grew up in well beyond his twenties.
Why was he so sick, he wondered? Something was dumping way too much adrenaline into his blood.
Coghlan told him he might have an adrenal tumor. But three scans of his adrenal glands all came back negative.
Discouraged but not deterred, Lindsay did the only thing he could do: He dove back into the medical literature.
And he came up with a treasure.
Later he diagnosed a disorder doctors didn't believe could exist
Lindsay suspected there might be something in his adrenal gland that acted like a tumor, but wasn't one.
A fourth scan in 2006 showed his adrenals "glowing brightly," Lindsay said, an abnormality consistent with his new theory.
Coghlan called Lindsay and said, "We found it!" The diagnosis: bilateral adrenal medullary hyperplasia.
In layman's terms, it means the medullas, or inner regions, of his adrenal glands were enlarged and acting like tumors. His adrenal glands were producing way too much adrenaline.
Experts in the field doubted the diagnosis. But Coghlan put his professional reputation on the line to back it.
As Lindsay delved into more medical literature, he found only 32 recorded cases of bilateral adrenal medullary hyperplasia.
And he fixed on what seemed like a simple solution: If he could cut out the medullas of his adrenal glands -- sort of like slicing into a hard-boiled egg and removing the yolk -- his health would improve.
Dr. Chris Bauer, Lindsay's personal physician, calls his ailment an "atypical presentation of a rare disease."
"They don't really write textbooks based on that," Bauer said. "We were were all learning with Doug as we went along."
Then he pioneered a new surgery
Lindsay finally came to a bold conclusion. "If there isn't a surgery," he decided, "I'm going to make one."
His first big lead came in 2008. He found a 1980 study from a scientist at Georgia State University, which he summed up as: "You slice the rat's adrenal gland with a razor blade and squeeze it so the medulla pops out like a pimple."
Then he found that another version of the adrenal medulla extraction had been done at Harvard. Renowned professor Walter Bradford Cannon had performed the surgery on cats in 1926. Lindsay found records of the surgery being done on dogs as well.
He built a 363-page PDF which proposed a first-ever human adrenal medullectomy.
Then he spent the next 18 months working to find a surgeon who would oversee the unorthodox procedure.
Pioneering a new surgery is a high-wire act for ethical and financial reasons as well. Surgeons could risk losing their license by performing an unproven operation, especially if complications arose. And insurance companies tend to not reimburse patients for non-standard procedures.
Because many of the doctors in that specialized field knew each other, Lindsay was careful where he pitched the idea that might save his life.
Eventually he recruited a surgeon from the University of Alabama-Birmingham. In September 2010 Lindsday went to the university hospital, where the doctor successfully extracted one of his adrenal medullas.
Three weeks after the procedure, Lindsay could sit upright for three hours. By Christmas Eve, he had the strength to walk a mile to church.
As he stood in the back of the church during midnight Mass, it finally felt like hope was winning.
But progress was slow. In 2012, he underwent a second surgery at Washington University in St. Louis to remove the medulla from his remaining adrenal gland.
A year later, he was well enough to fly with friends to the Bahamas. It was the first time in his life the Midwesterner had seen the ocean.
By early 2014, he was coming off some of his meds.
Coghlan, his champion, lived just long enough to see Lindsay's remarkable recovery. He died in 2015.
Against the odds, Lindsay had found a way to save himself.
But his mother was too delicate to be moved to another facility, let alone endure the surgery her son pioneered. She died in 2016.
She didn't get to see him walk across the stage to graduate that year from Rockhurst University with a bachelor's degree in biology, 16 years after he originally expected to begin his career.
Lindsay is now 41 years old. Many of the friends with whom he planned to graduate are now married, with kids in grade school.
In 2017 Lindsay shared his story to graduates at his alma mater, De Smet Jesuit High School in St. Louis
"You can't recapture the past," Lindsay said.
Today he still lives in his childhood home in St. Louis. He needs to take nine medications per day, and his health is far from perfect, but he has his life back.
He's not exactly the biology professor he dreamed of being at 21, but he's not far off the mark. He's leveraging his experience into a new career as a medical consultant.
"I couldn't be an assistant manager at Trader Joe's. I don't have the physical ability for that," Lindsay said. "But I can travel and give speeches and go for walks. And I can try to change the world."
Doctors are turning to him to help them identify and treat rare diseases like his own.
"I'm a full professor at Stanford, and I don't know these answers," said Dr. Lawrence Chu, who found himself leaning on Lindsay when a rare disease patient came to him. "Doug was the expert consultant."
Lindsay has spoken at medical schools, including Stanford and Harvard, and at a growing list of medical conferences. And he's working on a case study to be published in the British Medical Journal.
With his gift for solving intractable problems, he hopes to help steer other patients with hard-to-treat diseases on a path toward wholeness.
"I got help from people," he said, "and now I have to help people."
Dhaka, July 27 (UNB) - Most of us are familiar with the germ-fearing character of Dr Sheldon Cooper played by Jim Parsons in the CBS television series The Big Bang Theory. He is so apprehensive of germs and contracting an infection that he once even alienated his friend and moved to another table just because he sneezed. This fear of germs or contamination is termed as ‘Mysophobia’ and is very common.
“Mysophobia is often related to an obsessive-compulsive disorder (OCD). These obsessions are persistent, repeated and unwanted urges that often lead to distress and anxiety. People with Mysophobia struggle to comprehend which situations are unsafe, as they feel vulnerable and panic even while encountering daily scenarios which may involve even a probable chance of coming in contact with germs,” says Dr Binita Priyambada, senior consultant, medical team at Docprime.com.
Patients suffering from Mysophobia take stringent measure to avoid contamination and tend to keep the spaces they visit or live in, spick and span.
People with a history of depression or anxiety in their family are at a greater risk of contracting a phobia. Some people may develop this condition after experiencing a disturbing event, while others may simply focus on germs as a repercussion to their anxiety. Some experts are of the opinion that increased use of products such as hand sanitizers, and toilet seat covers, that promote hygiene, have significantly contributed to the rise of this condition.
People suffering from OCD are also at a greater risk for suffering from the condition as they may have obsessive thoughts and apprehensions relating to germs and this may lead them to feel the compulsion to sanitise or clean their surrounding including the workplace or house in order to stay wary of germs.
What are the possible symptoms of Mysophobia?
*Avoiding places which are perceived as dirty
*Spending a lot of time in cleaning and decontaminating the surroundings
*Obsessively washing hands
*Refusing the use and sharing of personal items
*Avoiding physical contact with others
*Avoiding crowded places
*When a person is exposed to germs, they may experience symptoms such as an increased heart rate, shortness of breath, panic, sweating, etc.
Complications associated with Mysophobia
As sanitisation levels have arisen in wealthy economies, doctors and scientists have noticed that auto immune or allergic diseases such as asthma and inflammatory bowel disease have started becoming much common among children of these countries. “In fact doctors have found correlation between lack exposure to common contaminants in childhood and these diseases. Most doctors now agree that children need to be exposed to various microorganisms in the surroundings in order to build a strong and self-sufficient immune system from an early age,” adds Dr Priyambada.
David Strachan first elaborated on this in the year 1989, calling it the “hygiene hypothesis”. The hypothesis stated that “people exposed to a diversity of microorganisms early in life lower their risk of allergic diseases like asthma, eczema, seasonal allergies, and even autoimmune disorders such as arthritis or inflammatory bowel disease.” This hypothesis has gained a lot of acceptance in the last few decades. Therefore, going overboard with taking preventive measures such as excessive use of decontaminants and sanitisers, in order to avoid exposure to germs inhibits the full development of the immune system. This puts the patient at a risk of contracting multiple ailments when exposed to normal flora and fauna in their environment.
What it means for everyday life is that while bathing and hand wash and basic cleaning practices are good for health, various commercial products marketed as antiseptic hand rubs, antibacterial soaps, vaginal wash etc. are best avoided.
Diagnosis and treatment
If the fear of germs interferes with a person’s daily life and s/he finds it difficult to socialise then a therapist must be consulted. The patient may visit a therapist at the earliest for timely diagnosis and treatment. If the therapist concludes that a person is suffering from Mysophobia, he may ask the patient to undergo some therapy sessions. The patient may also be prescribed medications to ensure that the symptoms do not worsen or aggravate.
However, in order to receive optimal treatment, the patient will need to be open up to the therapist so that the extent of the problem can be determined and an accurate treatment plan can be curated and implemented.
Dhaka, July 27 (UNB) - No matter what your skin type is, a good night skincare regime is a must for everyone. Our skin and body repair and rejuvenate themselves the most while we are asleep and that is when all products are known to work effectively. So it is vital to have an appropriate night time skincare routine which will help nourish and hydrate the skin.
To help you maintain the glow of your skin, Naina Ruhail, co-founder, Vanity Wagon shares a few simple tips to follow according to your skin type.
Oily skin: Everyone with oily skin must use gentle products that do not over-dry the skin, and also prevent breakouts. Start by removing your make-up with a gentle cleansing lotion, and follow up with an oil control face wash, and a toner to hydrate your skin. After cleansing and toning, make sure you pat on a facial oil to counter the loss of nourishment. In the end, moisturise with a light-weight and non-greasy formula to lock in the goodness. You must also scrub and mask twice a week to upkeep the skin, remove the dead skin cells, and unclog the pores.
Dry skin: If your skin feels tingly and tight, has a flaky appearance and tends to peel off in case you do not hydrate it properly then it needs intense nourishment and love. Dry skin often has a dull appearance and is also quite itchy, especially in extreme weather conditions. But you can balance your skin’s vital levels with an extensive night care routine.
Pick a chemical-free face wash to gently remove the dirt and impurities. Use rose water or an alcohol-free toner to restore the skin’s pH balance. Spray an activated hydrator, pat in a rich serum or facial oil and moisturise to set everything in. Make sure you wait a minute before each step to let the product seep in well.
Indulging in gentle scrubbing, masking and using a body butter is also a great way to prevent dryness.
Sensitive skin is very fragile and difficult to treat as it can react adversely to any product anytime. People with sensitive skin often suffer from unexpected redness and blotchiness when exposed to extreme weather conditions or even a slightly polluted environment. Though nothing can be done to change the skin type, one can surely treat it better with an effective and thoughtful nigh time routine.
Start with gently removing your makeup or dirt with cleansing milk and then wash it with a mild cleanser, followed by applying a toner. Then apply a healing and nourishing face oil. Facial oils soothe the easily irritable skin and prevent unexpected reactions. After applying the oil, moisturise as usual and get to bed.
Apart from following these routines, indulging in a stress-relieving bath, eating clean and working out also helps in keeping the skin healthy and glowing.
Dhaka, July 27 (UNB) - Gurmar or Gymnema Sylvestre is a tropical plant that is indigenous to India and grows wild in the tropical forests of central, western and southern parts of the country. The medicinal herb also grows in the tropical areas of Africa, Australia, and China. Known for its Ayurvedic properties, gurmar has proven to be beneficial in managing various ailments like diabetes, malaria and even snake bites and digestion issues. Due to the presence of flavonoids, cinnamic acid, folic acid, and ascorbic acid, gurmar leaves are high in antioxidants, reportsThe Indian Express.
A study published in Journal of Herbs, Spices & Medicinal Plants says that gurmar, which translates to ‘destroyer of sugar’, is rich in several active compounds like gymnemic acid, gymnemasides, anthraquinones, flavones, hentriacontane, pentatriacontane, phytin, resins, tartaric acid, formic acid, butyric acid, lupeol and alkaloid like gymnamine, which make it rich in antidiabetic properties.
According to WebMD, “Gymnema contains substances that decrease the absorption of sugar from the intestine. Gymnema may also increase the amount of insulin in the body and increase the growth of cells in the pancreas, which is the place in the body where insulin is made.”
It is said that having one teaspoon of powdered gurmar leaves with water half an hour after lunch and dinner may help regulate the absorption of carbohydrates in the body. Also, the gymnemic acids in the herb blocks the sugar receptors on your tongue, decreasing your ability to taste sweetness. This can lead to reduced sugar cravings.
The wonder herb is also known to aid weight loss with research indicating that consuming the leaves for 12 weeks can help reduce the body weight and body mass index in overweight people.