NO. It's missing key ingredients. Like allowing Medicare to negotiate pricing, or allowing Americans to buy drugs from Canada.
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SUMMARY: President Trump revealed his blueprint to lower prescription drug prices as he railed against the pharmaceutical industry for making them unaffordable. Under his plan, "American Patients First," Trump proposes making it easier for generic drugs to enter the market and requiring drug makers to list prices in advertising. John Yang gets reaction from David Mitchell of Patients for Affordable Drugs.
SUMMARY:Local law enforcement in Chillicothe, Ohio, have found their own way to respond to a slew of fatal opioid overdoses in their community. The 'Post Overdose Response Team' (PORT) sets out each week to find every person in their county who overdosed the week before and try to get them into treatment. Special correspondent Esther Honig of Side Effects Public Media has the story.
SUMMARY:Fake pharmaceuticals are a multi-billion dollar problem around the world. Made and packaged to look like the real deal, these phonies may contain a fraction of the active ingredients or none at all. These fake drugs can have serious consequences in countries with tenuous health care, as well as in the developed world. Special correspondent Fred de Sam Lazaro reports from Kenya.
SUMMARY:A promising lung cancer treatment from Cuba is getting attention from U.S. patients, some of whom are already traveling there to try the drug in hopes of stopping their cancer from growing. American doctors can't prescribe CIMAvax because the Food and Drug Administration won't approve it until U.S. clinical trials can prove its effectiveness. Special correspondent Amy Guttman reports.
SUMMARY: The abuse of opioids has become a major public health concern; more than 28,000 people died by overdose in 2014. According to reporting by STAT News, drug companies downplayed the addictive effects of opioid drugs in the late 1990s, assuring doctors that they could be safely used for chronic pain and incentivized their use. Hari Sreenivasan talks to journalist David Armstrong.
GWEN IFILL (NewsHour): The abuse of opioids remains a major public health concern around the country.
The federal government says more than 28,000 people died by overdose in 2014. That's the most recent year for nationwide data. The health news site STAT has been reporting on the problem and what has been driving it.
Journalist David Armstrong sat down with Hari Sreenivasan recently.
HARI SREENIVASAN (NewsHour): David, your investigation looks at a number of big pharmaceutical countries that you say helped sow the seeds for some of this epidemic that we have today. How so?
DAVID ARMSTRONG, STAT: Well, the way they sowed the seeds was by making this drug widely used.
And the way they did that was to downplay the addictive properties of this drug when marketing it to doctors, in a way that was later shown to be false and misleading.
HARI SREENIVASAN: Now, doctors can prescribe drugs off-label for something that it wasn't originally designed to, but how were the pharma companies abusing this?
DAVID ARMSTRONG: Well, they were primarily abusing it in the way they were assuring doctors that these powerful opioids that are a controlled substance would not be addictive in the way that they later proved to be addictive, and could be used for things like chronic pain, which we now know they're not very effective at.
So they were able to broaden the market through a series of misrepresentations and through a series of aggressive marketing tactics.
SUMMARY: The opioid epidemic sweeping the nation once more took center stage after law enforcement officials revealed that music icon Prince's death in April was due to an accidental overdose of fentanyl, a synthetic opioid far stronger than morphine. Hari Sreenivasan talks to Sharon Stancliff of the Harm Reduction Coalition for more on how we can reduce opioid fatalities with better addiction treatment.
HARI SREENIVASAN (NewsHour): The opioid epidemic and the problems of treatment.
Law enforcement officials told the Associated Press and The Minneapolis Star-Tribune today that music legend Prince died from an accidental opioid overdose in April. The superstar, according to reports, self-administered fentanyl, a synthetic opioid painkiller much stronger than morphine.
It's also been reported that Prince had an earlier overdose, and was then revived with a dose of a drug called Narcan. That treatment, and Prince's later attempt to get help from an addiction specialist, have cast a spotlight on the question of treatment for addiction.
Here to discuss this with us is Dr. Sharon Stancliff, medical director of the Harm Reduction Coalition, a national organization focusing on advocacy and the health care of those struggling with drug use.
Doctor, when you hear fentanyl, a fairly strong drug in all the classes of drugs, what does that make you think of what Prince was going through?
DR. SHARON STANCLIFF, Medical Director, Harm Reduction Coalition: Well, I understand Prince had a chronic pain problem, and fentanyl is often prescribed either as a patch or preparations that dissolve in the mouth for chronic pain.
We don't know if he had a prescription for that, but that's extremely likely. We also are hearing a lot about fentanyl in the news because there is illicitly manufactured fentanyl found in many parts of the country either mixed into heroin or sold as heroin.
So, we're hearing about a lot of fentanyl overdoses. They could be from pain management or they could be from illicit preparations.
HARI SREENIVASAN: When you see these stories and hear about these stories across the country, we're seeing, we're hearing more about people who get addicted while they're being treated for chronic pain.
DR. SHARON STANCLIFF: Right.
Well, anyone who takes an opioid on a repeated basis daily will become dependent upon the opioid. Many people will be able to, when the pain stops, taper off of the opioid and go on as though nothing had happened.
Others find that it's really hard to taper off, and once tapered off, they continue to have craving for that — an opioid for weeks, months, even years, and so that's why we have a variety of medications to treat opioid addiction or opioid use disorders.
SUMMARY: Shortages of some prescription drugs are forcing doctors to make difficult decisions, in some cases choosing one patient over another, or sharing a dose between multiple patients. Hari Sreenivasan learns more about the rationing from Sheri Fink of The New York Times.
HARI SREENIVASAN (NewsHour): Now; how shortages of some prescription drugs are forcing doctors to make difficult, often ethically fraught decisions, in some cases, choosing one patient over another to receive a much-needed drug, or splitting a single dose between two, even three patients.
For a look at what’s behind the rationing, how doctors and their patients are coping, and what might be done to correct the problem, we turn to Sheri Fink of The New York Times, who has been reporting on the story. In addition to being a reporter, she is also a medical doctor.
Dr. Fink, what’s interesting is, you’re talking about some of the best hospitals in the country that are going through this, not a small, faraway hospital where you might expect that there would be a shortage. This is kind of — paint us a picture of how widespread this issue is.
SHERI FINK, The New York Times:The shortages are affecting all types of hospitals, clinics, broad range of medical specialties. It has touched — in recent years, this problem has touched just about everywhere in America.
HARI SREENIVASAN: So, why is it happening? Is it specific types of drugs? Is it specific companies?
SHERI FINK: It has to do with, some of the drugs often are made by only one manufacturer. So, if something goes wrong in a quality sense, for example, and they have to shut down production, that could leave the market not having enough.
It could be that there’s not an economic incentive for a lot of drug companies to get into this. It could be that manufacturing chains that — in the factories are running all the time, and if one goes down, it can affect lots of different drugs.
So there are economic reasons, there are regulatory reasons. There are all sorts of reasons. And these shortages are becoming a fact of life. They have increased. In recent years, the number of new shortages increased. New federal law requiring manufacturers to tell the FDA if they see something like this on the horizon have decreased the number of new shortages, but the number of existing shortages is quite high.
Nah.... Big-Pharma really do care about customers being able to afford their drugs..... NOT! ...MORE $money$! or your life!
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SUMMARY: Turing Pharmaceuticals sparked outcry when it raised the price of a single pill from $13 to $750. Judy Woodruff discusses the rising costs of prescriptions drugs with Dr. Peter Bach of Memorial Sloan Kettering Cancer Center and Dr. Thomas Stossel of Harvard Medical School.
JUDY WOODRUFF (NewsHour): Now let’s turn to the rising price of prescription drugs and outcries to do something about it.
The latest uproar began after The New York Times reported how one company, Turing Pharmaceuticals, raised the price of a drug from $13 a pill to $750. It follows headlines about the rising costs of new cancer drugs, as well as a breakthrough drug for hepatitis C that initially cost more than $80,000 for a course of treatment.
The two leading Democratic candidates for president, Hillary Clinton and Bernie Sanders, are proposing big changes, including lowering patient costs and bigger discounts for Medicare.
Now two views on this.
Dr. Peter Bach is the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center. And Dr. Thomas Stossel is the director of translational medicine at Brigham and Women’s Hospital and a professor of medicine at Harvard Medical School.
And, gentlemen, we welcome you both.
Dr. Bach, I’m going to start with you.
Why is this happening?
DR. PETER BACH, Memorial Sloan Kettering Cancer Center: Well, it’s really that there’s no system in place the hold down drug prices, and so companies are just becoming increasingly bold, charging prices that they think the market will bear.
And Turing Pharmaceuticals and the 55-fold increase in the price of Daraprim is just a version of a company testing the market, if you will, just how high they can raise a price. But we see it across drugs, rapid inflation in the cost of drugs, not only new ones, but old ones.
JUDY WOODRUFF: Dr. Stossel, how do you explain it? It’s long been the case that there has been no system for keeping prices down. Why now?
DR. THOMAS STOSSEL, Harvard Medical School: Well, there still is no system, although people are asking for it.
Well, thank you for having me.
So, I have been in medicine for almost half-a-century, and it’s incredibly better because of the drugs that are available. So, drugs bring great value. There’s no question about it. Also, despite the fact there’s been uptake in costs in recent years, they still constitute less than, I think, 14 percent of total health care costs.
Now, in that 50 years, the price, the cost of what it takes to get a drug approved by the FDA has increased 100 times.
SUMMARY: More than 30 million Americans take statins to lower their cholesterol, according to estimates. But these popular drugs don't work for everyone. Now the FDA may be poised to approve a powerful new class of drugs that can attack cholesterol levels in a different way. Hari Sreenivasan talks to Dr. Steven Nissen of the Cleveland Clinic and Dr. Harlan Krumholz of the Yale School of Medicine.
HARI SREENIVASAN (NewsHour): The FDA will decide later this summer whether to follow the panel’s recommendations. But it usually does so. And the drugs, which are injected once or twice a month, have been shown to be effective at lowering bad cholesterol in early trials.
Still, larger trials need to be completed to see if they prevent heart attacks and strokes. And then there’s the question of how many people may ultimately take them. More than 70 million Americans have high LDL. Initially, they may cost around $10,000 a year per patient.
We talk to two cardiologists about these questions.
Dr. Stephen Nissen is the chair of cardiology at the Cleveland Clinic. For the record, he is leading a study of one of the drugs and is on the steering committee for a Pfizer clinical trial. He takes no money from the companies. And Dr. Harlan Krumholz is professor of cardiovascular medicine at the Yale School of Medicine.
So, Dr. Nissen, I want to ask, why is this class of drugs so interesting to you? What does this do that the medications that are on the shelf today don’t do?
DR. STEPHEN NISSEN, Chairman, Department of Cardiology, Cleveland Clinic: Well, LDL cholesterol is the primary driver of coronary heart disease, the most important risk factor that we can modify.
And we have great drugs called statin drugs, drugs like Zocor and Lipitor and so on, that are very effective at lowering LDL cholesterol and preventing heart attack, stroke and death.
But not everybody gets an adequate response to those drugs. Some people are genetically programmed to have very high levels of bad cholesterol, LDL, and they just don’t get well enough with those drugs. And there are other people that are intolerant of the drugs.
So we have needed another class of drugs. These drugs are really powerful. They lower LDL anywhere from 50 to 70 percent. And that’s additive on top of the effects of the statin drugs. So they’re very exciting, very powerful.
SUMMARY: Forty-six people die every day in the U.S. after overdosing on prescription painkillers, causing some states to crack down. Are tighter laws creating new problems? Judy Woodruff gets views from Bob Twillman of the American Academy of Pain Management and Dr. Andrew Kolodny of Physicians for Responsible Opioid Prescribing.
JUDY WOODRUFF (NewsHour):Each day, 46 people die in this country after overdosing on prescription painkillers. In 2012 alone, the CDC says 259 million prescriptions were written for painkillers, enough to supply every American adult with a bottle of pills.
Now many states are pushing back, including New York, Tennessee, Kentucky, Florida, and Washington State. Three of those states now require doctors to check a patient database before writing a prescription. This year, Massachusetts, Rhode Island, Georgia, and Texas are also considering tighter laws.
But some physicians and patient advocates say this crackdown is creating new problems.
We get two views now.
Dr. Andrew Kolodny is the director of Physicians for Responsible Opioid Prescribing. He’s also chief medical officer for the Phoenix House Foundation. It’s a national nonprofit addiction agency. Bob Twillman is the executive director of the American Academy of Pain Management and also a clinical psychologist at the University of Kansas Medical Center. Mr. Twillman was caught in a traffic jam tonight. He couldn’t make it to the studio, so he joins us by telephone.
A Novo Nordisk drug combining its long-acting insulin degludec with its type 2 diabetes treatment Victoza has been recommended for approval in Europe, in an important boost for the Danish company.
The European Medicines Agency said on Friday it had issued a positive opinion for Xultophy, previously known as IDegLira, implying the medicine is likely to be formally approved by the European Commission within three months.
Novo said it planned to launch Xultophy in the first European markets in the first half of 2015.
Jakob Riis, executive vice president of marketing and medical affairs at Novo Nordisk, said Britain, Germany and Denmark were likely to be among the first launch markets for the product.
Clinical trial results have shown that the once-daily injection lowers blood sugar more than each medicine taken on its own, setting a new standard for sugar control in diabetic patients.
Prospects for degludec - already on sale separately in Europe under the brand name Tresiba - and the new combination with Victoza are critical for Novo, which is the world's biggest insulin maker.
Shares in Novo gained 1.6 percent on news of the favorable European decision, outperforming the European drugs sector which slid 0.3 percent by 1200 GMT.
Victoza has been a major growth driver for the group in the past few years but its sales are now rising more slowly, and Novo suffered a major setback in 2013 when U.S. regulators demanded more data on the safety of Tresiba before approving it.
With diabetes affecting 382 million people worldwide and the number of cases expected to rise to 592 million by 2035, according to the International Diabetes Federation, the disease represents a huge market for pharmaceutical companies.
Novo's main rivals in the space are Sanofi and Eli Lilly, which are also major suppliers of insulin.
Combination therapies for the growing type 2 diabetes health crisis are becoming increasingly common as patients continually require additional medicines as the disease progresses.
In addition to good blood sugar control, patients taking Xultophy also tend to lose weight. Weight loss is a particularly beneficial effect as obesity is a leading cause of type 2 diabetes and insulin tends to cause weight gain.
SUMMARY:Are generic drugs being delayed to market by so-called "pay for delay" deals between drug companies? The deals happen after generic drug companies challenge the patents on brand-name drugs. The settlements include a date that the generic drug can enter the market, and in some cases, a payment from brand company to the generic company.
MEGAN THOMPSON (NewsHour): In 2004, Karen Winkler was diagnosed with multiple sclerosis, a debilitating disease affecting the nervous system. The 46-year-old mother of three, who lives in Clarkston, Michigan, struggles every day with numbness, pain and extreme fatigue.
KAREN WINKLER: It’s so overwhelming. You wake up tired. And as the day progresses, it just gets worse and worse. And it’s where you could fall asleep standing up.
MEGAN THOMPSON: In 2005, Winkler’s doctor prescribed a brand-name medication called Provigil. It was one of the only drugs for fatigue on the market that had minimal side effects. It was made by a company called Cephalon, which earned $475 million dollars on Provigil that year. Winkler’s doctor put her on a half pill, every day.
KAREN WINKLER: It was perfect, you know. I had three young kids and I could still do- pretty much do everything that I did. And, you know, if I had 10 things on the to-do list, you know, I could either get the 10 things done or at least eight or nine of them.
MEGAN THOMPSON:Better yet, Winkler says her doctor told her Provigil was expected to go generic soon – possibly within a year. And that could have saved Winkler more than a thousand dollars a year. The potential savings were especially important because her disease made it impossible to go back to work as she’d planned. And around that same time, her husband’s pay was cut and the family had to dip into savings and a 401(k).
KAREN WINKLER:Then it didn’t go generic. And it was a whole different story. ---- MEGAN THOMPSON: Why hadn’t Provigil gone generic? And why was the price of it rising so sharply? As Winkler discovered through online research, the company manufacturing the drug, Cephalon, was using two common but little known business strategies that critics say end up costing consumers. First, there’s something that opponents call, “pay for delay.”
MEGAN THOMPSON: Here’s how “pay for delay” works. According to the Federal Trade Commission, when generic manufacturers challenge a patent, the brand-name manufacturer sometimes pays to keep the generic version off the market.
MEGAN THOMPSON:In the case of Karen’s drug, the company that makes Provigil paid a total of $200 million to four generic companies. That deal guaranteed no generic would come to market for another six years. ---- MEGAN THOMPSON: But because of what critics describe as those “pay for delay” deals, Provigil didn’t go generic. So Karen Winkler and other consumers paid the price. And it turns out she paid even more because of that second controversial business strategy that Cephalon used then and other drug manufacturers continue to use today — something opponents call “evergreening.” The idea is to get consumers off the drug they’re taking and on to another brand drug the same company is making.
MEGAN THOMPSON: In Winkler’s case — off Provigil whose patent was about to expire. — and onto Nuvigil, whose patent had several years to run. Companies sometimes do this by jacking up prices on the first drug. That’s what happened to Winkler when, seeking relief from the rising price of Provigil, her doctor offered her Nuvigil.
KAREN WINKLER: So, I thought, “Great. You know, here’s a solution.” Came home and I started taking the pills for two or three days and got a pounding, pounding headache from it. And, to the point that it was almost like having a migraine.
MEGAN THOMPSON: That’s when Winkler went online and figured out what was going on.
KAREN WINKLER: And what they were trying to do was to get patients off of Provigil, because they knew it was going to be going generic shortly, to start taking this Nuvigil that had this new, extended patent period. And then obviously once Provigil went generic, everybody on Nuvigil would not be going to a generic drug. They would be still on the Nuvigil.
SUMMARY:In May, Colorado became the first state to pass a so-called 'right to try' law, allowing terminal patients access to experimental drugs without FDA approval -- and Missouri is about to follow suit.NewsHour Weekend examines the issue by speaking with the Missouri bill's sponsor and his daughter, who is suffering from cancer.
STEPHEN FEE (NewsHour): In early 2013, Kristina Brogan was pregnant with her fifth child when she began experiencing excruciating pain — and her obstetrician didn’t know why.
KRISTINA BROGAN: Finally my mom went with me to an appointment and said you got to find out why she’s hurting so bad. So they did a level two ultrasound at St. Luke’s and admitted me immediately.
STEPHEN FEE: Why? What did they find?
KRISTINA BROGAN: They found the tumor. And they’d found it had gone up into my liver.
STEPHEN FEE: Kristina, at the age of 39, was diagnosed with stage four colorectal cancer.
STEPHEN FEE: What was that like?
KRISTINA BROGAN: Scary.
STEPHEN FEE: What was running through your head?
KRISTINA BROGAN: I can’t say I had a – a normal thought in my head. I was just scared. Scared for my baby. Scared for me. Scared for my family.
STEPHEN FEE: Her doctors needed to take aggressive measures to fight the disease and chose to perform a C-section, just 28 weeks into Kristina’s pregnancy. Today, her son Evan is a happy and healthy one-year old. Kristina however is battling a disease with dispiriting odds even with regular chemotherapy treatment.
JUDY WOODRUFF (NewsHour): When you see headlines about a new drug on the market, chances are you have rarely thought about the gender of the lab animal the drug was first tested on during trials, but, in fact, most early trials are conducted on male rats or other male animals.
Researchers say that gender difference has led to a significant impact after a drug comes to market. Last week, the National Institutes of Health announced that it is requiring scientists to test their work on both male and female animals.
For some insight into what’s behind these changes and what it means, we turn to Dr. Janine Clayton. She’s the director of the National Institutes of Health’s Office of Research on Women’s Health. That’s the agency that announced the change. And Phyllis Greenberger, she’s the president of the Society for Women’s Health Research. She has long advocated for this change.
SUMMARY: A new drug has a 90 to 100 percent chance of curing the Hepatitis-C virus, but costs tens of thousands of dollars for a course of treatment. The announcement by the manufacturer that it earned more than $2 billion in the year’s first quarter raises the question, who should pay when drugs are highly effective, but extremely expensive? Hari Sreenivasan reports on the profits, coverage and costs.
JUDY WOODRUFF (NewsHour): ....Who should pay when drugs are very effective, but extremely expensive?
That’s an important question for the U.S. health care system as new treatments come along, and it’s a matter of real concern over a new drug that has a 90 percent to 100 percent chance of curing the Hepatitis-C virus. Its manufacturer announced record sales yesterday of more than $2 billion in just the first quarter of the year.
Profits, coverage and costs are all at issue, as Hari Sreenivasan reports.
HARI SREENIVASAN (NewsHour): Kim Bossley knows how fragile life can be. In 2005, Bossley was diagnosed with Hepatitis-C, a blood-borne virus that can destroy the body’s liver.
KIM BOSSLEY: I went from stage one to stage four, decomposed liver, very quickly.
HARI SREENIVASAN: News of her rapidly declining health was devastating for the 46-year-old mother of two.
KIM BOSSLEY: You fall into a depression when you’re diagnosed with Hep-C. Your own mortality rate hits you.
DR. GREGORY T. EVERSON, University of Colorado Hospital: That’s a pretty good response.
HARI SREENIVASAN: This fall, after nine years of battling the virus, Kim Bossley was accepted into a treatment trial with a new drug called Sovaldi.
DR. GREGORY T. EVERSON: So, Kim, we will check your labs here.
HARI SREENIVASAN: Almost immediately after taking Sovaldi, the Hepatitis-C virus disappeared.
Big Pharma’s focus on blockbuster cancer drugs squeezes out research into potential treatments that are more affordable. Says one researcher: “What is scientific and sexy is driven by what can be monetized.”
Michael Retsky awoke from surgery to bad news. The tumor in his colon had spread to four of his lymph nodes and penetrated the bowel wall. When Retsky showed the pathology report to William Hrushesky, his treating oncologist, the doctor exclaimed, "Mamma mia."
"Michael had a mean looking cancer," Hrushesky remembers.
Retsky didn't need anyone to tell him his prognosis. Although trained as a physicist, he had switched careers to cancer research in the early 1980s and spent more than a decade modeling the growth of breast cancer tumors. During his treatment, he joined the staff of one of the most prestigious cancer research labs in the country.
In the absence of chemotherapy, there was an 80 percent chance of relapse. Even with therapy, there was a 50 percent chance the cancer would return. The standard treatment was brutal. Six months of the highest dose of chemotherapy his body could withstand and, after that, nothing but hope.
Like many cancer patients, Retsky didn't much like the odds. Unlike most cancer patients, however, he had the knowledge to question them. His own research had sown doubts that standard chemotherapy, as used the world over to treat colon and some breast cancers, was always the best approach. In collaboration with Hrushesky, the two devised an inexpensive, low-impact chemo treatment following surgery that dripped smaller doses of the drug into his body over a longer period of time.
Seventeen years later and cancer free, Retsky cannot be entirely sure the treatment cured him, but he believes it likely did. Numerous laboratory, animal and small human studies suggest that low-dose, continuous chemotherapy holds promise in shrinking tumors and preventing cancer's recurrence. But the next step — testing what Retsky did in a large-scale clinical trial — is a long-shot given the way cancer treatments are developed today.
Take Michelle Holmes, an associate professor of medicine at Harvard Medical School. She's been trying for years to raise money for trials on the effects of aspirin on breast cancer. Animal studies, in vitro experiments and analysis of patient outcomes suggest that aspirin might help inhibit breast cancer from spreading. Yet even her peers on scientific advisory boards appear uninterested, she says.
"For some reason a drug that could be patented would get a randomized trial, but aspirin, which has amazing properties, goes unexplored because it's 99 cents at CVS," says Holmes.
Increasingly, Big Pharma is betting on new blockbuster cancer drugs that cost billions to develop and can be sold for thousands of dollars a dose. In 2010, each of the top 10 cancer drugs topped more than $1 billion in sales, according to Campbell Alliance, a health-care consulting firm. A decade earlier, only two of them did. Left behind are low-cost alternatives — therapies like Retsky's or existing off-label medications, including generics — that have shown some merit but don't have enough profit potential for drug companies to invest in researching them.
The newer drugs have in some cases shown dramatic life-extending results for patients. Yet cancer remains the second-most-common cause of death in the U.S. after heart disease, killing about 580,000 people a year. Worldwide, 60 percent of all cancer deaths occur in developing countries, where experts say the incidence of the disease is growing rapidly, as is a desperate need for affordable care. That has added urgency to an active debate about whether efforts to combat cancer — and where to put scarce research dollars — need to be rethought.
"If we are winning the war on cancer, we are not winning that fast," says Vikas Sukhatme, Harvard faculty dean for academic programs at Beth Israel Deaconess Medical Center in Boston and the Victor J. Aresty Professor of Medicine at Harvard Medical School.
Sukhatme and his wife Vidula, an epidemiologist, are among those trying to do something about it. They have spearheaded a new nonprofit, Global Cures, to promote alternative treatments that are unlikely to attract commercial interest from drug companies.
Global Cures calls these forsaken therapies, " financial orphans." To help patients and their doctors, the nonprofit is producing reports that explain the science behind promising orphan therapies — those that have shown merit in animal studies and limited human data. And Global Cures also has set itself a more challenging goal — to find the money for clinical trials.
In one example, Retsky and a team of collaborators are exploring whether an inexpensive dose of a generic painkiller before breast cancer surgery might reduce lethal recurrences of the disease. If results in a small retrospective study of 327 mastectomy patients in Europe were to bear out, the anti-inflammatory drug Ketorolac could save thousands of lives a year in the United States alone, Sukhatme has estimated.
The data behind the treatment are only suggestive, however, and more testing is required. Retsky and his colleagues have been unable to raise the millions of dollars a large-scale trial would need to make a real determination, in part because no drug company has the incentive to fund such a study, they say.
Without the confirmation of large-scale human trials, doctors are reluctant to approve patient use of orphan therapies, even in cases where there is little else to offer. It's a challenging conversation when a patient suggests an alternative medication to a doctor, who despite having the ability to prescribe off-label, doesn't want to risk making the situation worse. "It borders on crossing the line between good evidence-based medicine and simply trying to deal with the desperate hopes of desperate patients," says Allen Lichter, chief executive officer of the American Society of Clinical Oncology. Nonetheless, Lichter acknowledges that there are financial orphans that do not get the review they deserve.
The financial orphan problem points to a deeper issue with the way cancer drugs are developed. Pharmaceutical companies exist to make a profit and cannot be expected to cover many important areas of research that go unexplored, according to Larry Norton,deputy physician-in-chief for Breast Cancer Programs at New York's Memorial Sloan Kettering Cancer Center. It's a gap in the system.
"The biggest challenge we have today is not necessarily the science," Norton says, "it's creating a business model that makes sense."
SUMMARY: A new study from Stanford University's School of Medicine found that doctors who are allowed to hand out free samples of expensive drugs prescribe those drugs more often than doctors who don’t have access to free samples. Dr. Alfred Lane, senior author of the report, talks with Hari Sreenivasan about the implications of the findings.
HARI SREENIVASAN (Newshour): The recommendations by the nation's leading heart organizations are the first new cholesterol guidelines released since 2004.
For decades, doctors have prescribed cholesterol-lowering statins to their patients based on their laboratory numbers. But the new recommendations focus on risk factors, including whether individuals have diabetes or heart disease, or if they have a level of so-called bad cholesterol known as LDL. That's 190 or higher.
Dr. Harlan Krumholz is a cardiologist and a professor of medicine at the Yale School of Medicine who has long studied this issue.
So, Dr. Krumholz, how significant are these new guidelines?
When Heather Dougherty heard the news last week that the Food and Drug Administration had recommended tightening how doctors prescribed the most commonly used narcotic painkillers, she was overjoyed. Fourteen years earlier, her father, Dr. Ronald J. Dougherty, had filed a formal petition urging federal officials to crack down on the drugs.
Dr. Dougherty told officials in 1999 that more of the patients turning up at his clinic near Syracuse were addicted to legal narcotics like Vicodin and Lortab that contain the drug hydrocodone than to illegal narcotics like heroin.
Since then, narcotic painkillers, or opioids, have become the most frequently prescribed drugs in the United States and have set off a wave of misuse, abuse and addiction. Experts estimate that more than 100,000 people have died in the last decade from overdoses involving the drugs. For his part, Dr. Dougherty, who foresaw the problem, retired in 2007 and is now 81 and living in a nursing home.
“Too many lives have been ruined,” his daughter said.
The story behind the F.D.A.’s turnaround on the pain pills, last Thursday, involved a rare victory by lawmakers from states hard hit by prescription drug abuse over well-financed lobbyists for business and patient groups, one that came during a continuing public health crisis.
Just last year, Representative Fred Upton, Republican of Michigan — the House’s biggest recipient during the last election cycle of drug industry campaign contributions, with nearly $300,000 — blocked a measure that would have imposed the restrictions the F.D.A. backed last week.
Among the provisions in the bill, pushed by Senator Joe Manchin III, Democrat of West Virginia, was one that is central to the new F.D.A. recommendations: reducing to 90 days the length of time in which a patient could obtain refills for painkillers containing hydrocodone without a doctor visit. The drugs are now widely sold by generic producers.
Mr. Upton, who is the chairman of the House Energy and Commerce Committee, argued that imposing new limits would harm patients who needed the drugs, which are used to treat pain from injuries, arthritis, dental extractions and other problems. That stance was echoed by patient groups, lobbyists representing drug makers, pharmacy chains like Walgreens and CVS, local drugstores and physicians groups like the American Medical Association.
The F.D.A.’s long resistance to added restrictions on the drugs underscores what critics say is its continuing struggle to address the complexities of the painkiller problem in its often conflicting roles — one as a regulator that approves drugs and the other as a drug safety watchdog.
On Friday, public health advocates who had cheered the agency’s decision the day before were dismayed when the F.D.A. approved a new, high-potency painkiller despite an 11-2 vote by an expert panel of its own advisers not to do so. The panel concluded in December that the long-acting opioid, called Zohydro, could lead to the same type of abuse and addiction as OxyContin.
SUMMARY: While millions of people use prescription painkillers for relief, their abuse has reached epidemic levels in some places. To combat rising addiction rates, the FDA has a new plan to limit the distribution of pain meds, specifically containing hydrocodone. Hari Sreenivasan gets more from Barry Meier of The New York Times.
JEFFREY BROWN (Newshour): A rare but deadly outbreak of meningitis is raising concerns for thousands of patients nationwide, and sparking questions about the way certain pharmacies are regulated.
The outbreak has been linked to tainted steroid injections used to help fight back pain. The medication was distributed by a pharmacy located just outside of Boston.
The New England Compounding Center had already recalled the steroid. And on Saturday, it issued a voluntary recall for all of its products from the Framingham, Mass., site.
But it came too late for 105 people who contracted a rare form of fungal meningitis, including eight who died. Family members say the victims were stricken with little warning.
I am Retired U.S. Navy (22yrs) and a Vietnam Veteran. After my Navy retirement I was in the computer related industry, now retired. In 2000 I was a registered Republican and voted for George W. Bush. Six months of having Bush in the Whitehouse forced me to re-evaluate my political stance. I had always thought of myself as a Moderate Republican, but was a Republican by "default" NOT because of close examination of the GOP. Due to what has happened in America since 2000, I now consider myself a progressive, and registered as a Non-Affiliated voter.
*Anti-First Amendment policies that attempt to turn America into a theocracy by enshrining ANY religious belief as law.
* Any attempt to suppress human or Constitutional rights.
* Any law or policy that supports discrimination based on religion, ethnicity, race/color, gender, sexual orientation, or any law that does NOT support Equal Treatment under the law.
*Any law or policy that attempts to suppress Freedom of the Press or Free Speech.
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