by Walter Eininkel - The Daily KOS - April 13, 2018
On April 10 in the year of our Lord, 2018, analysts at Goldman Sachs allegedly released a report titled “The Genome Revolution.” According to numerous news reports, the report delved into a pretty awkward subject—cures.
"The potential to deliver 'one shot cures' is one of the most attractive aspects of gene therapy, genetically-engineered cell therapy and gene editing. However, such treatments offer a very different outlook with regard to recurring revenue versus chronic therapies," analyst Salveen Richter wrote in the note to clients Tuesday. "While this proposition carries tremendous value for patients and society, it could represent a challenge for genome medicine developers looking for sustained cash flow."
It isn’t “good business,” to be absolutely frank. We all know it isn’t. There are entire fringe worlds of conspiracy that continue to exist based on this one single kernel of truth. Why is this news now? Because science and medicine are getting very close to big and meaningful breakthroughs on diseases and maladies that were once only somewhat treatable with very expensive routines of medications. Gene therapy breakthroughs have been a big part of this, with the FDA approving promising gene therapy trials, and even more exciting results coming in from around the world. But as CNBC reports, solving serious problems for the public doesn’t mean you get to keep buying mega-yachts. Goldman Sachs analyst Salveen Richter has some bad news for our current “free market” system:
Richter cited Gilead Sciences' treatments for hepatitis C, which achieved cure rates of more than 90 percent. The company's U.S. sales for these hepatitis C treatments peaked at $12.5 billion in 2015, but have been falling ever since. Goldman estimates the U.S. sales for these treatments will be less than $4 billion this year, according to a table in the report."GILD is a case in point, where the success of its hepatitis C franchise has gradually exhausted the available pool of treatable patients," the analyst wrote. "In the case of infectious diseases such as hepatitis C, curing existing patients also decreases the number of carriers able to transmit the virus to new patients, thus the incident pool also declines … Where an incident pool remains stable (eg, in cancer) the potential for a cure poses less risk to the sustainability of a franchise."
The fact of the matter is that private industry spends a lot of money on scientific research because it’s extraordinarily profitable. But, governments spend money on scientific research as well, and some political parties believe that one of the many things our government should help to do, besides funding the arts and education, is to foster scientific research and innovation. Our current Republican-led government does not believe in that, having already laid out massive cuts to scientific research. They believe that private interests can innovate the best way possible to the best outcomes for the most people.
“Is curing patients a sustainable business model?” Goldman Sachs analysts ask
Analyst report notes that Gilead’s hep C cure will make less than $4 billion this year.
by Beth Mole - Ars Technica - April 12, 2018
One-shot cures for diseases are not great for business—more specifically, they’re bad for longterm profits—Goldman Sachs analysts noted in an April 10 report for biotech clients, first reported by CNBC.
The investment banks’ report, titled “The Genome Revolution,” asks clients the touchy question: “Is curing patients a sustainable business model?” The answer may be “no,” according to follow-up information provided.
Analyst Salveen Richter and colleagues laid it out:
The potential to deliver “one shot cures” is one of the most attractive aspects of gene therapy, genetically engineered cell therapy, and gene editing. However, such treatments offer a very different outlook with regard to recurring revenue versus chronic therapies... While this proposition carries tremendous value for patients and society, it could represent a challenge for genome medicine developers looking for sustained cash flow.
For a real-world example, they pointed to Gilead Sciences, which markets treatments for hepatitis C that have cure rates exceeding 90 percent. In 2015, the company’s hepatitis C treatment sales peaked at $12.5 billion. But as more people were cured and there were fewer infected individuals to spread the disease, sales began to languish. Goldman Sachs analysts estimate that the treatments will bring in less than $4 billion this year.
“[Gilead]’s rapid rise and fall of its hepatitis C franchise highlights one of the dynamics of an effective drug that permanently cures a disease, resulting in a gradual exhaustion of the prevalent pool of patients,” the analysts wrote. The report noted that diseases such as common cancers—where the “incident pool remains stable”—are less risky for business.
To get around the sustainability issue overall, the report suggests that biotech companies focus on diseases or conditions that seem to be becoming more common and/or are already high-incidence. It also suggests that companies be innovative and constantly expanding their portfolio of treatments. This can “offset the declining revenue trajectory of prior assets." Lastly, it hints that, as such cures come to fruition, they could open up more investment opportunities in treatments for “disease of aging.”
Ars reached out to Goldman Sachs, which confirmed the content of the report but declined to comment.
This post has been updated.
How Profiteers Lure Women Into Often-Unneeded Surgery
by Matthew Goldstein and Jessica Silver-Greenberg - NYT - April 14, 2018
Jerri Plummer was at home in Arkansas, watching television with her three children, when a stranger called to warn that her life was in danger.
The caller identified herself only as Yolanda. She told Ms. Plummer that the vaginal mesh implant supporting her bladder was defective and needed to be removed. If Ms. Plummer didn’t act quickly, the caller urged, she might die.
Ms. Plummer, 49, didn’t ask many questions. Her implant was causing her discomfort, and she was impressed by how much Yolanda knew about her medical history. She was scared. “It was like I had a ticking time bomb inside of me,” she said. Yolanda assured Ms. Plummer that all her expenses would be covered and that she would be set up with a lawyer to help her sue the mesh manufacturer, Boston Scientific.
Days later, court records show, Ms. Plummer was lying on an operating table in a medical office in a shopping mall in Orlando, Fla.
Just like that, she had stumbled into a growing industry that makes money by coaxing women into having surgery — sometimes unnecessarily — so that they are more lucrative plaintiffs in lawsuits against medical device manufacturers.
Lawyers building such cases sometimes turn to marketing firms to drum up clients. The marketers turn to finance companies to provide high-interest loans to the clients that have to be repaid only if the clients receive money from the case. Those loans are then used to pay for surgery performed by doctors who are often lined up by the marketers.
Interviews with dozens of women, lawyers, finance executives and marketers, as well as a review of court records and confidential documents, indicate that hundreds, perhaps thousands, of women have been sucked into this assembly-line-like system. It is fueled by banks, private equity firms and hedge funds, which provide financial backing.
The profits are immense. So are the costs to women. Some suffer physical problems from the surgery. Others say they have become depressed or unable to work. Still others have to get mesh reinserted.
Ms. Plummer’s brush with the industry left her wearing diapers.
The industry of providing financing to law firms involved in litigation is not new. In recent years, it has expanded into a diverse array of businesses. A spate of companies, such as a Brooklyn outfit named Law Cash, have popped up to provide upfront cash to plaintiffs hoping for big legal settlements.
The litigation surrounding mesh implants is a lucrative niche. These so-called mass tort cases, some of which began six years ago when problems with the implants started to arise, encompass claims brought by tens of thousands of women who say they were harmed by the same products.
Millions of women worldwide received mesh implants. They are used to correct a condition called pelvic organ prolapse, which occurs when a woman’s organs fall and press against her vagina because of weakened pelvic muscles. That causes urinary and other problems. The mesh reinforces the pelvic wall.
But many women complained that the implants caused problems such as bleeding and discomfort during sex.
Litigation against the implants’ manufacturers, including Boston Scientific and Johnson & Johnson, proliferated. There are more than 100,000 plaintiffs in federal court alone. Many more are involved in litigation at the state level or outside the United States.
Representatives of Boston Scientific and Johnson & Johnson said they stood by the quality of their products. The mesh manufacturers have set aside more than $3 billion to cover potential mesh-related settlements.
Not all plaintiffs are equal. Some law firms — which are paid a percentage of any settlements — realized that women with the implants still in their bodies tended to receive smaller settlements than those who had them taken out.
“Defendants have offered next to nothing to settle cases involving mesh products that have not been removed,” Ms. Plummer’s lawyers at McSweeney Langevin, a small Minneapolis personal injury firm, wrote in a letter advising her to get the implant taken out.
Rhett McSweeney, a co-founder of the law firm, said in a statement that the firm never forced clients to undergo unnecessary surgery and “never directed a client to a particular doctor.”
Plaintiffs’ firms turned to marketers to recruit clients. Women with mesh implants said they soon started receiving torrents of unsolicited phone calls, some originating overseas. The women said they didn’t know how these marketers had found them and seemed to know their medical histories.
“I think my privacy was breached,” said Jennifer Godsoe, 66, who lives in Cumberland, Me. “The more I think about it, the more upset I get.”
Some women had vague memories of answering an online ad about mesh problems. The only thing linking some other women was that they previously had the same doctors, court records show.
Women who took the marketing bait were connected to doctors willing to perform the mesh-removal surgery — although that process remains murky. One critical player was Surgical Assistance, a Florida company led by Wesley Blake Barber, which acted as a middleman between the women, doctors and funding companies. Mr. Barber’s lawyer declined to comment.
In a deposition last summer, Mr. Barber outlined how the company had lined up doctors in Florida and Georgia to perform the surgery. In one online ad, an actor in a white lab coat assures women suffering from their mesh implants that relief is near. By calling a toll-free number, the women will be set up with a “network of qualified surgeons” who remove the mesh without requiring upfront payments.
Women who opted for surgery were flown to Florida and Georgia, put up in motels and sent to walk-in clinics, court filings show. The women generally didn’t meet the doctors who would be operating on them until shortly before the procedure. Before going under the knife, few women got a second opinion.
Dan Christensen, a lawyer who ran MedStar Funding, which financed mesh removal surgery, said in an interview that it was “ludicrous” to argue that women had undergone unnecessary surgery.
“You have to have a doctor willing to put his license on the line,” he said. “Why jeopardize your license?”
$14,000 a Day
The work was lucrative. Doctors stood to make $14,000 a day.
Doctors sometimes churned through four or five removals in a day. Each procedure typically cost about $21,000, according to lawsuits brought by women against the mesh manufacturers. Of that, doctors pocketed roughly $3,500 per surgery; most of the rest went to the medical centers where the surgery took place.
Law Cash offered Danette Charnetzky, a hospice worker in Waynesburg, Ohio, financing for a removal surgery in December 2014. Ms. Charnetzky, another McSweeney client, agreed to pay the money back, at a double-digit interest rate, if the litigation was successful. Within a week, she and her husband were on a plane to a surgical center in a Florida strip mall. The process was a terrifying blur.
“I wish I could have changed my mind, but we were already there,” said Ms. Charnetzky, 49, who hasn’t received any money from the pending litigation against the mesh manufacturer. “I just prayed for the best.”
She got the worst — or something close to it. Ms. Charnetzky said she had needed two more procedures to repair scar tissue left by the Florida surgery.
Rhonda Espeland, 63, who was living in Arizona, also had a bad experience. Since her mesh implant was removed in January 2015, she has developed incontinence. “I may need another surgery,” she said.
The bladder problems have left Ms. Espeland unable to work, and she hasn’t received any money from litigation against her mesh manufacturer. Boxes of diapers are regularly delivered to her door.
The doctor who performed her surgery — and similar procedures on hundreds of others — was Earle M. Pescatore. In March 2014, around the time that he started doing lots of procedures, Mr. Pescatore and his wife filed for bankruptcy, citing liabilities of $1.5 million, including $38,000 they owed to the Internal Revenue Service, according to court filings. Dr. Pescatore said in a deposition that he had little memory of women he operated on.
“Any treatment that Dr. Pescatore provided would have been medically necessary,” his lawyer, Mark DiCowden, said.
While studies have shown that up to 15 percent of women with mesh implants will encounter problems, removing the mesh is not always recommended. Taking it out is more complicated than inserting it because the mesh is made of fiber that is designed to bond with tissue.
Many of the women who got the surgery had limited or no health insurance. They rarely discussed the surgery with their primary care physicians before arriving at the clinics. Some said they had felt rushed into getting surgery.
Dr. Victor Nitti, a surgeon specializing in complex pelvic issues at NYU Langone Health in New York, said serious mesh problems should be addressed with surgery. But, he said, “scaring a patient who has limited to no symptoms into removal is just dangerous and irresponsible.”
Dr. Nitti said he had grown concerned about such scare tactics after some patients told him that they had been contacted by marketers.
A handful of specialized finance firms funded the surgery that Ms. Plummer, Ms. Espeland and other women got. Court filings show that the two main players are Law Cash and Banyan Finance of Boca Raton, Fla., and that the firms charge double-digit interest rates.
Ross Elgart, Banyan’s chief executive, did not respond to requests for comment.
Lew Fidler, Law Cash’s general counsel, said financing surgical procedures such as Ms. Plummer’s is a small portion of the company’s business. He said the firm, which typically provides cash advances to help plaintiffs pay for everyday expenses, ensures that each surgery is necessary.
“I feel for anyone who didn’t get the outcome they were looking for, but we are not doctors,” Mr. Fidler said. “We don’t substitute our judgment for a licensed physician.”
Law Cash, like other firms, is paid back for a surgical advance only if the person gets a settlement. The firms contend that high interest rates cover the risk that some borrowers will never collect settlements. Some women, however, said the high interest rates had never fully been explained to them.
As a result of those steep interest rates, plaintiffs who do collect settlements see much of the money go to the financing firms. Another large slice goes to their lawyers.
Medical funding for personal injury litigants was a topic of discussion Friday in Las Vegas at the mass tort industry’s big annual conference, titled “Mass Torts Made Perfect.” Law firms are eyeing mesh used to treat hernias as the next gold mine.
The industry has grown thanks in part to a gusher of money from mainstream financial institutions. Law Cash gets funding from DZ Bank, Germany’s second-largest bank, and Melody Capital Partners, a hedge fund with $1.8 billion in assets.
McSweeney Langevin, which has represented more than 1,000 women in mesh litigation, got backing from EJF Capital, a Virginia hedge fund with $10 billion in assets, according to corporate records.
Many of McSweeney’s clients initially were signed up by a now-defunct law and marketing firm, Alpha Law. The Washington firm had signed up 14,000 women for the mesh litigation. Its unusual role in the litigation was the subject of a series of Reuters articles.
The industry tries to keep the network of marketers and financiers out of sight — and some participants have refused to answer questions in depositions, citing their Fifth Amendment right against self-incrimination.
“People are claiming the Fifth and so on and so forth,” said Magistrate Judge Cheryl Eifert in West Virginia, who is hearing one of the mesh cases in federal court. “They don’t have to talk about necessarily how much money they make, per se, but if someone would just give them an idea of how the arrangement works. But nobody’s willing to do that.”
Mr. Barber of Surgical Assistance, for example, asserted the privilege nearly two dozen times in a deposition.
Swollen Like Balloons
Jerri Plummer never figured out whom Yolanda worked for. But in December 2014, Dr. Whitney Shoemaker performed the implant-removal surgery. Until the day of the operation, Ms. Plummer had never spoken to Dr. Shoemaker. Her lawyer declined to comment.
Hours after Ms. Plummer went under the scalpel, she said, she was hustled back to a Hampton Inn just off the freeway, with a catheter sticking out of her side. The next day, a nurse arrived at the motel, removed the catheter and put her in a taxi to the airport.
Soon after she arrived home in Arkansas, she said, complications developed. Her legs swelled like balloons. Her stomach seized up. Ms. Plummer went to her original doctor for help, she said. He informed her that the damage was irreversible. Worse, she said in court records, he told her that there had been no need for the removal surgery.
Before the surgery, Ms. Plummer loved to take walks with her two pit bulls and to eat with her husband at Red Lobster. Now chronic incontinence forces her to wear diapers all day and has left her too worried about wetting herself to venture outside.
With the help of a local lawyer, James R. Baxter, she is suing Law Cash; Dr. Shoemaker; Mr. Barber and his firm, Surgical Assistance; and lawyers at the McSweeney firm.
Mr. McSweeney declined to comment on the lawsuit. His firm is trying to get Ms. Plummer’s lawsuit moved from federal court into private arbitration, where there is no judge or jury. In his statement, he said the firm “had no role” connecting clients with surgical funders like Law Cash or Banyan Finance.
The law firm now has clients sign a waiver that advises them that cash advances to pay for surgery “are terrible loans with extremely high interest rates.”
Ms. Plummer said she had never received such a warning. She feels that she was victimized twice — first by the mesh manufacturer and then by her lawyers and doctor. “I was taken advantage of through this whole process,” she said.
The Disappearing Doctor: How
Mega-Mergers Are Changing
the Business of Medical Care
Big corporations — giant retailers and health insurance
companies — are teaming up to become your doctor.
companies — are teaming up to become your doctor.
by Reed Abelson and Julie Crewel - NYT - April 7, 2018
Is the doctor in?
In this new medical age of urgent care centers and retail clinics, that’s not a simple question. Nor does it have a simple answer, as primary care doctors become increasingly scarce.
“You call the doctor’s office to book an appointment,” said Matt Feit, a 45-year-old screenwriter in Los Angeles who visited an urgent care center eight times last year. “They’re only open Monday through Friday from these hours to those hours, and, generally, they’re not the hours I’m free or I have to take time off from my job.
“I can go just about anytime to urgent care,” he continued, “and my co-pay is exactly the same as if I went to my primary doctor.”
People are flocking to retail clinics and urgent care centers in strip malls or shopping centers, where simple health needs can usually be tended to by health professionals like nurse practitioners or physician assistants much more cheaply than in a doctor’s office. Some 12,000 are already scattered across the country, according to Merchant Medicine, a consulting firm.
On the other side, office visits to primary care doctors declined 18 percent from 2012 to 2016, even as visits to specialists increased, insurance data analyzed by the Health Care Cost Institute shows.
There’s little doubt that the front line of medicine — the traditional family or primary care doctor — has been under siege for years. Long hours and low pay have transformed pediatric or family practices into unattractive options for many aspiring physicians.
And the relationship between patients and doctors has radically changed. Apart from true emergency situations, patients’ expectations now reflect the larger 24/7 insta-culture of wanting everything now. When Dr. Carl Olden began watching patients turn to urgent care centers opening around him in Yakima, Wash., he and his partners decided to fight back.
They set up similar clinics three years ago, including one right across the street from their main office in a shopping center.
The practice not only was able to retain its patients, but then could access electronic health records for those off-site visits, avoiding a bad drug interaction or other problems, said Dr. Olden, who has been a doctor for 34 years.
“And we’ve had some folks come into the clinics who don’t have their own primary care physicians,” he said. “So we’ve been able to move them into our practice.”
The new deals involving major corporations loom over doctors’ livelihoods, intensifying pressure on small practices and pushing them closer to extinction.
The latest involves Walmart and Humana, a large insurer with a sizable business offering private Medicare plans. While their talks are in the early stages, one potential partnership being discussed would center on using the retailer’s stores and expanding its existing 19 clinics for one-stop medical care. Walmart stores already offer pharmacy services and attract older people.
In addition, the proposed $69 billion merger between CVS Health, which operates 1,100 MinuteClinics, and Aetna, the giant insurer, would expand the customer bases of both. The deal is viewed as a direct response to moves by a rival insurer, UnitedHealth Group, which employs more than 30,000 physicians and operates one of the country’s largest urgent-care groups, MedExpress, as well as a big chain of free-standing surgery centers.
While both CVS and UnitedHealth have large pharmacy benefits businesses that would reap considerable rewards from the stream of prescriptions generated by the doctors at these facilities, the companies are also intent on managing what type of care patients get and where they go for it. And the wealth of data mined from consolidation would provide the companies with a map for steering people one way or another.
On top of these corporate partnerships, Amazon, JP Morgan and Berkshire Hathaway decided to join forces to develop some sort of health care strategy for their employees, expressing frustration with the current state of medical care. Their announcement, and Amazon’s recent forays into these fields, are rattling everyone from major hospital networks to pharmacists.
Doctors, too, are watching the evolution warily.
“With all of these deals, there is so much we don’t know,” said Dr. Michael Munger, president of the American Academy of Family Physicians. “Are Aetna patients going to be mandated to go to a CVS MinuteClinic?”
Constant Changes in Care
Dr. Susan Kressly, a pediatrician in Warrington, Pa., has watched patients leave. Parents who once brought their children to her to treat an ear infection or check for strep, services whose profits helped offset some of the treatments she offered, are now visiting the retail clinics or urgent care centers.
What is worse, some patients haven’t been getting the right care. “Some of the patients with coughs were being treated with codeine-based medicines, which is not appropriate at all for this age group,” Dr. Kressly said.
Even doctors unfazed by patients going elsewhere at night or on weekends are nervous about the entry of the corporate behemoths.
I can’t advertise on NBC,” said Dr. Shawn Purifoy, who practices family medicine in Malvern, Ark. “CVS can.”
Nurse practitioners allow Dr. Purifoy to offer more same-day appointments; he and two other practices in town take turns covering emergency phone calls at night.
And doctors keep facing new waves of competition. In California, Apple recently decided to open up its own clinics to treat employees. Other companies are offering their workers the option of seeking medical care via their cellphones. Investors are also pouring money into businesses aiming to create new ways of providing primary care by relying more heavily on technology.
An Absence of Proof
Dr. Mark J. Werner, a consultant for the Chartis Group, which advises medical practices, emphasized that convenience of care didn’t equal quality or, for that matter, less expensive care.
“None of the research has shown any of these approaches to delivering care has meaningfully addressed cost,” Dr. Werner said.
Critics of retail clinics argue that patients are given short shrift by health professionals unfamiliar with their history, and may be given unnecessary prescriptions. But researchers say neither has been proved in studies.
“The quality of care that you see at a retail clinic is equal or superior to what we see in a doctor’s office or emergency department,” said Dr. Ateev Mehrotra, an associate professor of health care policy and medicine at Harvard Medical School, who has researched the retail clinics. “And while there is a worry that they will prescribe antibiotics to everybody, we see equal rates occurring between the clinics and doctor’s offices.”
Still, while the retail clinics over all charge less, particularly compared with emergency rooms, they may increase overall health care spending. Consumers who not long ago would have taken a cough drop or gargled with saltwater to soothe a sore throat now pop into their nearby retail clinic for a strep test.
Frustration with the nation’s health care system has fueled a lot of the recent partnerships. Giant companies are already signaling a desire to tackle complex care for people with a chronic health condition like diabetes or asthma.
“We’re evolving the retail clinic concept,” said Dr. Troyen A. Brennan, the chief medical officer for CVS. The company hopes its proposed merger with Aetna will allow it to transform its current clinics, where a nurse practitioner might offer a flu shot, into a place where patients can have their conditions monitored. “It requires new and different work by the nurse practitioners,” he said.
Dr. Brennan said CVS was not looking to replace patients’ primary care doctors. “We’re not trying to buy up an entire layer of primary care,” he said.
But people will have the option of using the retail clinic to make sure their hypertension or diabetes is well controlled, with tests and counseling provided as well as medications. The goal is to reduce the cost of care for what would otherwise be very expensive conditions, Dr. Brennan said.
If the company’s merger with Aetna goes through, CVS will initially expand in locations where Aetna has a significant number of customers who could readily go to CVS, Dr. Brennan said.
UnitedHealth has also been aggressively making inroads, adding a large medical practice in December and roughly doubling the number of areas where its OptumCare doctors will be to 75 markets in the United States. It is also experimenting with putting its MedExpress urgent care clinics into Walgreens stores.
Big hospital groups are also eroding primary care practices: They employed 43 percent of the nation’s primary care doctors in 2016, up from 23 percent in 2010. They are also aggressively opening up their own urgent care centers, in part to try to ensure a steady flow of patients to their facilities.
HCA Healthcare, the for-profit hospital chain, doubled its number of urgent care centers last year to about 100, according to Merchant Medicine. GoHealth Urgent Care has teamed up with major health systems like Northwell Health in New York and Dignity Health in San Francisco, to open up about 80 centers.
“There is huge consolidation in the market right now,” said Dr. Jeffrey Le Benger, the chief executive of Summit Medical Group, a large independent physician group in New Jersey. “Everyone is fighting for the primary care patient.” He, too, has opened up urgent care centers, which he describes as a “loss leader,” unprofitable but critical to managing patients.
Eva Palmer, 22, of Washington, D.C., sought out One Medical, a venture-backed practice that is one of the nation’s largest independent groups, when she couldn’t get in to see a primary care doctor, even when she became ill. After paying the annual fee of about $200, she was able to make an appointment to get treatment for strep throat and pneumonia.
“In 15 minutes, I was able to get the prescriptions I needed — it was awesome,” Ms. Palmer said.
Patients also have the option of getting a virtual consultation at any time.
By using sophisticated computer systems, One Medical, which employs 400 doctors and health staff members in eight major cities, allows its physicians to spend a half-hour with every patient.
Dr. Navya Mysore joined One Medical after working for a large New York health system, where “there was a lot of bureaucracy,” she said. She now has more freedom to practice medicine the way she wants and focus more on preventive health, she said.
By being so readily available, One Medical can reduce visits to an emergency room or an urgent care center, said Dr. Jeff Dobro, the company’s chief medical officer.
As primary care doctors become an “increasingly endangered species, it is very hard to practice like this,” he said.
But more traditional doctors like Dr. Purifoy stress the importance of continuity of care. “It takes a long time to gain the trust of the patient,” he said. He is working with Aledade, another company focused on reinventing primary care, to make his practice more competitive.
One longtime patient, Billy Ray Smith, 70, learned that he needed cardiac bypass surgery even though he had no symptoms. He credits Dr. Purifoy with urging him to get a stress test.
“If he hadn’t insisted,” Mr. Smith said, “it would have been all over for me.” Dr. Purifoy’s nurse routinely checks on him, and if he needs an appointment, he can usually see the doctor that day or the next.
“I trust him 100 percent on what he says and what he does,” Mr. Smith said.
Those relationships take time and follow-up. “It’s not something I can do in a minute,” Dr. Purifoy said. “You’re never going to get that at a MedExpress.”
Weighing the Pros and Cons of Statins
by Jane Brody - NYT - April 16, 2018
Are you among the 73 million Americans with cholesterol levels that current guidelines suggest should be lowered by taking a statin for the sake of your cardiovascular well-being? Have you and your doctor discussed the pros and cons of statin therapy and whether it is appropriate for your circumstances?
If not, now is the time to do so. Too often, patients are given a prescription with little or no discussion of what the drug can mean for their health, and that affects their willingness to take it or stay on it.
Dr. Seth Martin, a preventive cardiologist at Johns Hopkins Hospital, strongly recommends that taking a statin be a fact-based, collaborative and personalized decision between doctor and patient, following one or more discussions of the individual’s medical and personal concerns.
Maybe you’ve already been prescribed a statin and are among the 45 percent of such patients who never took the medication or who abandoned it within six months, perhaps because you’ve heard scary stories about possible side effects.
If so, I’m not surprised. Bad news about drugs travels fast, and reports of side effects are often exaggerated and rarely presented in a way that is meaningful to those who might be affected. (The same is true for a drug’s benefits, which are often described with statistics that mean little to the average person.) Misinformation, or misinterpretation of factual information, can result in what doctors call the “nocebo” effect — the experience of an anticipated side effect even when the patient is given a dummy pill.
A personal example: After being on a statin for nearly two decades to lower a genetically influenced high cholesterol level, I recently decided to take a drug holiday after reading about how the medication can affect muscle metabolism and sometimes cause muscle pain and damage.
Was the statin, I wondered, and not my age, the reason I was finding it harder to cycle, walk and swim? Could this otherwise valuable medication contribute to my back pain?
“A person’s expectation of the effects of statins can result in the experience of symptoms and relating those symptoms to the drug,” Dr. Martin explained. Thus, I may feel better without the statin even if the drug is not responsible for my symptoms. Regardless of the outcome, I expect to return to the statin lest I succumb to a “premature” heart attack, as my father and grandfather did.
As an international team of researchers pointed out in The Lancet in 2016, “exaggerated claims about side-effect rates with statin therapy may be responsible for its underuse among individuals at increased risk of cardiovascular events. For, whereas the rare cases of myopathy and any muscle-related symptoms that are attributed to statin therapy generally resolve rapidly when treatment is stopped, the heart attacks or strokes that may occur if statin therapy is stopped unnecessarily can be devastating.”
Unlike medications prescribed to treat a symptom or illness, statins are often given to healthy people to prevent a potentially devastating health problem, and the drug must be taken indefinitely to do the most good. Nearly half of Americans with cholesterol levels that put them at high risk of a heart attack or stroke are not taking medication to reduce that risk, according to the Centers for Disease Control and Prevention. Under current guidelines, among people 60 and older, 87 percent of men and 54 percent of women not already taking a statin would be considered eligible for treatment.
There is no question that statins can protect the health of people who have already had a heart attack or stroke (or even angina) and thus face a significant risk of a recurrence that could prove fatal. But many people — especially those who are uncomfortable taking drugs for any reason — resist taking a daily statin if they have no history or symptoms of cardiovascular disease, only a risk of developing them, especially since it has not yet been proven that the drugs help such people live longer.
Furthermore, people correctly regard “risk” as a possibility, not a probability, and vary in the degree of risk they are willing to tolerate. One chance in 100 may be acceptable to one person, while another may regard one chance in 1,000 as too risky.
Doctors define cardiovascular risk as a percentage chance of a heart attack or stroke occurring within the next 10 years based on the presence of well-established risk factors: high cholesterol, high blood pressure, smoking, diabetes, age, gender and race (and, in some cases, family history). You can determine your own risk using the calculator developed by the American College of Cardiology and American Heart Association at cvriskcalculator.com.
If your calculated risk is 7.5 percent or higher, your doctor is likely to suggest you consider taking a statin, although a relatively high cholesterol level may not result in such a recommendation if you have no other heart risk factors. The risk score is meant “to start a conversation, not to write a prescription,” according to Dr. Don Lloyd-Jones, professor of preventive medicine at Northwestern University Feinberg School of Medicine and a spokesman for the heart association.
Let’s say your risk is 19 percent. That means among 100 people with similar risk factors, 19 are likely to have a heart attack or stroke within the next decade. Is that a risk you’re willing to take? Or would you rather reduce your risk by a third by taking a statin? Only you can make that determination, and it should be based on a full understanding of the known benefits and risks of statins, not something you may have heard from a friend or read online.
The current labeling on statin prescriptions doesn’t help matters. In 2012, the Food and Drug Administration ruled that the warnings should include several reversibleside effects: confusion and memory loss, liver problems, increases in blood sugar and muscle weakness, as well as interactions with certain other medications.
But the label doesn’t state how rarely such problems occur, and reading the list of possibilities could scare off some people, especially those already timid about taking a lifelong drug.
The longer someone is on statin therapy, the greater the reduction in the risk of a cardiovascular event. The drug works primarily by lowering blood levels of harmful LDL cholesterol that can otherwise collect inside arteries that feed the heart and brain. It also helps to stabilize existing plaque, lowering the chances that a chunk will break loose and trigger a heart attack or stroke. There are also several different statins available that vary in potency and side effects, and all leading brands are now available as inexpensive generics.
Drug Company ‘Shenanigans’ to Block Generics Come Under Federal Scrutiny
by Robert Pear - NYT - April 14, 2018
WASHINGTON — Trump administration officials, seeking ways to lower drug costs, are targeting pharmaceutical companies that refuse to provide samples of their products to generic drug companies, making it impossible to create inexpensive generic copies of a brand-name medicine.
Dr. Scott Gottlieb, the commissioner of the Food and Drug Administration, said recently that drug makers must “end the shenanigans” that prevent competing products from reaching the market.
Generic drug developers need samples of brand-name drugs to show that a generic copy is equivalent to the original. The maneuvers by brand-name drug firms, Dr. Gottlieb said, “frustrate the ability of generic firms to purchase the doses of a branded drug that they need to run their studies.”
The Federal Trade Commission is investigating the practice, which it says can forestall generic competition and “potentially preserve a brand firm’s monopoly indefinitely.”
Federal officials said they were focusing on the anticompetitive practices of brand-name drug makers under the impetus of a vow by President Trump to hold down prices set by drug companies, which he has said are “getting away with murder.”
Legislation to ensure access to drug samples for generic drug manufacturers has broad support in Congress, from Senator Patrick J. Leahy, Democrat of Vermont, on the left to Senator Mike Lee, Republican of Utah, on the right. A similar bill in the House also has diverse backers, including Representatives Peter Welch, Democrat of Vermont, and Mark Meadows, Republican of North Carolina, who is the chairman of the conservative House Freedom Caucus.
Under the bill, a generic drug developer could file a lawsuit, and a federal court could require a brand-name drug maker to provide samples of its product to a generic company “on commercially reasonable, market-based terms.” The court could also award damages if it found that a drug maker had refused to sell samples “without a legitimate business justification.”
Brand-name drug companies make several arguments against the legislation. First, they say, it is not needed. The F.D.A. approved 1,027 generic drugs last year, a record number, and nearly 90 percent of prescriptions are filled with generic medicines, suggesting that generic manufacturers have generally been able to obtain the samples they need, the brand-name companies say.
Second, they say, the bill would be a boon to trial lawyers, giving them an incentive to sue brand-name pharmaceutical companies for damages, which could be worth more than sales of the proposed generic drug.
Finally, they say, the legislation could endanger patients because generic drug developers might not follow the strict safety protocols that the government requires for some brand-name drugs.
But the F.D.A. says that “no additional requirements are needed to protect patient safety” in tests to show the equivalence of generic and brand-name drugs. The “testing typically involves a relatively small number of human subjects and a small number of doses and therefore a relatively low level of risk,” the agency said.
At a time when researchers are using sophisticated science to develop new treatments and cures, the fight over physical samples — a few thousand pills — sounds mundane. But it has huge implications for consumers’ access to affordable medicines.
The F.D.A. says it has received more than 150 inquiries from generic drug companies unable to obtain the samples needed to show that a generic product works the same as a brand-name medicine. Some of the disputes over samples involve drugs that are costly to patients and to the Medicare program and that have experienced sharp price increases in recent years.
“Without generic competition, there is no pressure to drive down the costs of these medications,” the food and drug agency said. Under current law, it said, it cannot compel a brand-name drug manufacturer to sell samples to a generic company.
The Congressional Budget Office estimates that the legislation would save the federal government $3.8 billion over 10 years, mainly because Medicare, Medicaid and other health programs would spend less on prescription drugs. Savings for consumers and private health insurance plans could be much greater.
Lawmakers of both parties pushed for the legislation to be included in a far-reaching budget bill signed by Mr. Trump in February, but it was dropped at the last minute.
Even without action by Congress, generic drug companies say the denial of drug samples needed for testing may violate federal antitrust law because it tends to perpetuate a monopoly for the makers of some brand-name medications. But it typically takes years for courts to resolve such claims.
Mylan, a generic drug company, wants to obtain samples to develop a generic version of Revlimid, a brand-name cancer medicine sold by Celgene. At a court hearing in Newark in December, Jonathan M. Jacobson, a lawyer for Mylan, told a federal district judge that “Revlimid costs patients who are dying $20,000 a month.”
“These are some of the most ill patients in the world,” he said, and “if there were generics on the market, the price would be much lower, and people would live longer.”
Celgene said in court papers that it had no obligation to help a potential competitor and that it had “valid business justifications for declining to sell samples on the terms demanded by Mylan.” Moreover, Celgene said its overriding concern was for the safety of patients.
But Mylan, the generic drug company, said this was no excuse because it had devised safety protocols similar to those followed by Celgene.
The secretary of health and human services, Alex M. Azar II, has repeatedly said that drug prices are too high. The administration, he said, will soon roll out “a whole slate” of proposals to reduce those prices.
Mr. Azar has suggested that private companies — pharmacy benefit managers — should have a role in negotiating prices for drugs under Part B of Medicare. Those drugs are typically administered by infusion or injection in doctor’s offices and hospital outpatient departments.