Archive for the ‘Finance and Politics of cancer research and treatment’ Category

What Hospitals Won’t Tell You – Vital Strategies that Could Save Your Life

Comments Off
Posted 01 Apr 2012 — by James Street
Category Finance and Politics of cancer research and treatment, Hospital Safety, Iatragenic

By Dr. Mercola

Dr. Andrew Saul has over 35 years of experience in natural health education, and holds a number of certificates for teaching clinical nutrition.

He’s a recipient of the Citizens for Health Outstanding Health Freedom Activist Award, and was named as one of the seven natural health pioneers by Psychology Today.

Dr. Saul is currently editor-in-chief of The Orthomolecular Medicine News Service, and has authored over 100 publications and seven books, including Hospitals and Health: Your Orthomolecular Guide to a Shorter Hospital Stayi, which is the topic of this interview.

He is perhaps most prominently known for his appearance in the film Food Matters.

Hospitals and Health

Dr. Saul co-authored Hospitals and Health with Dr. Steve Hickey, and Dr. Abram Hoffer, the famous Canadian psychiatrist who, in 1953, demonstrated that high doses of niacin could cure schizophrenia and other similar mental disorders.

“Dr. Hoffer, in his study of biochemistry… noted that over the years there had been attempts to treat psychiatric illnesses by communities that didn’t have hospitals. One was the Quaker community. And the Quakers, Dr. Hoffer said, found that if they took the mentally ill; put them in a nice house, gave them good food, and gave them compassionate care, they had a 50 percent cure rate,” Dr. Saul says.

“Dr. Hoffer commented that drugs have about 10 percent cure rate. He was thinking that drugs might actually be going in the wrong direction, and hospitals give a lot of drugs… When people go into the hospital, they’re going to have problems… Statistically, there are so many errors in hospitals that the average works out to one error per patient per day at the minimum. If you’re in a hospital for four days, you can expect four medical errors in that time.”

According to the 2011 Health Grades Hospital Quality in America  noticed doctors or hospitalStudyii, the incidence rate of medical harm occurring in the United States is estimated to be over 40,000 harmful and/or lethal errors each and EVERY day.

Hospitals have become particularly notorious for spreading lethal infections. In the United States, more than 2 million people are affected by hospital-acquired infections each year, and a whopping 100,000 people die as a result. According to the Health Grades report, analysis of approximately 40 million Medicare patients’ records from 2007 through 2009 showed that 1 in 9 patients developed such hospital-acquired infections! The saddest part is, most of these cases could likely have been easily prevented with better infection control in hospitals—simple things such as doctors and nurses washing their hands between each patient, for example.

Hospitals, home and nursing home care account for over one-third of the $2.6 trillion the United States spends for health care.iii This is TRIPLE what we surrender to drug companies. It wouldn’t be so bad if we actually received major benefits for this investment, but, as Dr. Saul’s book reveals, this oftentimes is not the case…

Hospital Nutrition and Supplements

However, there are solutions; it is possible to make hospitals better, and the book addresses this in depth. Nutrition is a key element. As Dr. Saul points out, hospital food is almost universally associated with bad food. Most of it is highly processed, but you can sometimes get better fare simply by asking for a vegetarian meal. He also explains why it can be helpful to get a simple note from your primary care physician if you take vitamins and want to continue taking them while in the hospital. And, your rights, should the staff insist you can’t take them while staying there.

“If you want to take vitamins in the hospital, go ahead and do it,” Dr. Saul says. “On the other hand, if the hospital, your physician, or surgeon, can explain to you why, for a particular procedure or a particular medication, you cannot take the vitamin, then you can accommodate that request if they are highly specific. Usually what happens is they’ll say,

“You can’t take any vitamins.” But that’s just not true. Everyone should take vitamin C before they go to the hospital. They should take vitamin C before they go to the dentist for less infection, less pain, quicker healing time, and less bleeding. The same is true with surgery. People who take high doses of vitamin C are much less likely to have blood clotting in healing, inflammation, and other complications that, unfortunately, are fairly familiar among surgical staff.

If someone says, “You can’t take vitamin E because we’re going to give you Warfarin (Coumadin),” that’s a reasonable point. But then… there is evidence that if you take the vitamin E, you don’t need Warfarin.

I had a client once who had this exact dilemma. He had thrombophlebitis, and he was on Warfarin. He wanted to take vitamin E instead… He said, “Well, what should I do?” I said, “The best thing to do is to gradually decrease the drug with your doctor’s cooperation while increasing the vitamin – again, with your doctor’s cooperation. Talk to your doctor. The doctor that put you on the drugs should be the one that you’ll talk to about the drugs.”… He said, “I don’t want to talk to the doctor about this.” He actually was afraid to talk to his doctor. He did not want the confrontation. What he did instead was he just started taking the vitamin E. Eventually, his clotting time was extended to the point where the doctor said,

“What’s going on?”

… Too much Warfarin causes extended bleeding. Too much vitamin E can also cause slightly extended bleeding, but not out of the normal range. I said to him… “You got to talk to your doctor. If your doctor’s asking what’s going on, [then] tell him. He’ll take you off the Coumadin.” The fellow talked to the doctor, and the doctor took him off the vitamin E…”

Unfortunately, that’s a typical example of “standard care.” Dr. Saul, on the other hand, believes one of the first things doctors need to do is to make sure each patient has a multivitamin with each meal. The same goes for inmates in prisons, and senior citizens in nursing homes.

“Diets in institutions are terrible,” Dr. Saul says. “We can change that right away. People have to refuse the crap that they put on the plate and demand fresh, whole, unprocessed food. If enough people do that, the hospitals will do it. This is something that we can do. Vitamins, multivitamin supplements we can do…

The next thing that you can do is demand to be addressed by your title. Do not let them call you by your first name. You are a Mr., Ms., Mrs., or a Dr. This is a small point seemingly, but it can actually change your care.

Another thing that people need to do when they go into the hospital, and I got this from a nurse herself, she said, “Bring a guard.

I would never let a family member go into the hospital alone. Make absolutely sure that a friend or family member is with them 24 hours a day.” What does this do? It makes sure that mistakes aren’t made, or if mistakes are made, you’ve got a witness. At the very least, the person is going to have some company. That’s something we can do. Not everybody has an advocate. Not everybody has family members available, but this is still a doable situation. What else can we do about hospitals? We can avoid them…”

Knowing How to Play “the Hospital Game” Can Help Keep You Alive

One of the reasons I am so passionate about sharing the information on this site about healthy eating, exercise, and stress management with you is because it can help keep you OUT of the hospital. But if you do have to go there, you need to know how to play the game.

“Dr. Steve Hickey is an authority on game theory, cybernetics, and all kinds of mathematical stuff…” Dr. Saul says. “Dr. Hickey wrote a chapter in Hospitals and Health specifically on the “hospital game” and how to play it. He… demonstrates that the outcome depends on you… If you just go in… [they] take you to bed and you keep quiet, you’re what Dr. Hoffer calls a “pious patient.”

Pious patients tend to get killed.

… The lowest estimate makes hospitals one of the top 10 causes of deaths in the United States… The highest estimate makes hospital and drugs the number one cause of death in the United States…

We can fix this problem. We can make a change. But the only way it’s going to happen is if you know how to play the game. That’s why Hospitals and Health – I think – will really come in handy. Abraham Hoffer practiced for 55 years. He ran hospitals. He had so much experience, and what does it still boil down to? Common sense – good food, good care, as few drugs as possible, and taking charge of your own health.”

Why Avoiding Elective Procedures During July May Be a Lifesaving Choice

What’s my personal recommendation when it comes to hospital stays? Naturally, my number one suggestion is to avoid hospitals unless it’s an absolute emergency and you need life-saving medical attention. In such cases, it’s worth taking Dr. Saul’s recommendation to bring a personal advocate; a relative or friend who can speak up for you and ensure you’re given proper care if you can’t do so yourself.

If you’re having an elective medical procedure done, remember that this gives you greater leeway and personal choice—use it!

Many believe training hospitals will provide them with the latest and greatest care, but they can actually be more dangerous. As a general rule, avoid elective surgeries and procedures during the month of July because this is when brand new residents begin their training. According to a 2010 report in the Journal of General Internal Medicine, lethal medication errors consistently spike by about 10 percent each July, particularly in teaching hospitals, due to the inexperience of new residents.iv Also be cautious of weekends.

“Sometimes, your best bet for a hospital is a relatively small local one,” Dr. Saul advises.

Who has the MOST Power During Your Hospital Stay?

“The most important thing to remember is this: the hospital power structure,” Dr. Saul says. “No matter what hospital you go in… Maybe you’ve got to be in a teaching hospital. Maybe you don’t have a lot of choices. Maybe you are there because of financial issues. Maybe it’s because of geographical issues. Maybe it’s because it was an emergency, and you woke up in the hospital. Maybe you have to be there on a weekend…

The question is, “Are you going to walk out the front door, or be wheeled out the back?”

Now, here’s what people need to do. They need to understand that when they are faced with hospitalization, the most powerful person in the most entire hospital system is the patient.

The system works on the assumption that the patient will not claim that power… You might have set that up with a document. If you have a power of attorney, a living will, or other types of paperwork or someone is responsible, then we know who’s responsible. But let’s say that it’s just an ordinary situation—the patient has the most power.

A patient can say, “No. Do not touch me.” And they can’t. If they do, it’s assault, and you can call the police. Now, they might say, “Well, on your way in, you signed this form.”

You can unsign it. You can revoke your permission. Just because somebody has permission to do one thing, it doesn’t mean that they have the permission to do everything. There’s no such thing as a situation that you cannot reverse. If you can make amendments to the U.S. Constitution, you can change your mind about your own personal healthcare. It concerns your very life. You don’t want to cry wolf for no reason, but the patient has the potential to put a stop to anything; absolutely anything.

If the patient doesn’t know that, if they’re not conscious, or if they just don’t have the moxie to do it, the next most powerful person is the spouse. The spouse has enormous influence and can do almost as much as the patient. If the patient is incapacitated, the spouse can probably do much more than the patient.

If there is no spouse present, the next most powerful people in the system are the children of the patient… You’ll notice that I haven’t mentioned doctors or hospital administrators once. That’s because they don’t have the power. They really don’t. They just want you to think that you do. It is an illusion that they run the place. The answer is – you do. They’re offering you products and services, and they’re trying to get you to accept them without question.

… [W]hen you go to the hospital, bring along a black Sharpie pen, and cross out anything that you don’t like in the contract. Put big giant X’s through entire clauses and pages, and do not sign it. And when they say, “We’re not going to admit you,” you say, “Please put it in writing that you refuse to admit me.” What do you think your lawyers are going to do with that? They have to [admit you]. They absolutely have to…

It’s a game, and you can win it. But you can’t win it if you don’t know the rules. And basically, they don’t tell you the rules. In Hospitals and Health, we do.”

The book, Hospitals and Health is available through any online bookseller, including Amazon, or you can order an autographed copy at www.DoctorYourself.com. Knowing how to prevent disease so you can avoid hospitals in the first place is clearly your best bet. But knowing what to do to make your hospital stay as safe and healing as possible is equally important. For the inside scoop, I highly recommend reading the book.

References:

In cancer science, many “discoveries” don’t hold up

Comments Off
Posted 31 Mar 2012 — by James Street
Category Ethics of Science, Finance and Politics of cancer research and treatment

Photo
Wed, Mar 28 2012

By Sharon Begley

NEW YORK (Reuters) – A former researcher at Amgen Inc has found that many basic studies on cancer — a high proportion of them from university labs — are unreliable, with grim consequences for producing new medicines in the future.

During a decade as head of global cancer research at Amgen, C. Glenn Begley identified 53 “landmark” publications — papers in top journals, from reputable labs — for his team to reproduce. Begley sought to double-check the findings before trying to build on them for drug development.

Result: 47 of the 53 could not be replicated. He described his findings in a commentary piece published on Wednesday in the journal Nature.

“It was shocking,” said Begley, now senior vice president of privately held biotechnology company TetraLogic, which develops cancer drugs. “These are the studies the pharmaceutical industry relies on to identify new targets for drug development. But if you’re going to place a $1 million or $2 million or $5 million bet on an observation, you need to be sure it’s true. As we tried to reproduce these papers we became convinced you can’t take anything at face value.”

The failure to win “the war on cancer” has been blamed on many factors, from the use of mouse models that are irrelevant to human cancers to risk-averse funding agencies. But recently a new culprit has emerged: too many basic scientific discoveries, done in animals or cells growing in lab dishes and meant to show the way to a new drug, are wrong.

Begley’s experience echoes a report from scientists at Bayer AG last year. Neither group of researchers alleges fraud, nor would they identify the research they had tried to replicate.

But they and others fear the phenomenon is the product of a skewed system of incentives that has academics cutting corners to further their careers.

George Robertson of Dalhousie University in Nova Scotia previously worked at Merck on neurodegenerative diseases such as Parkinson’s. While at Merck, he also found many academic studies that did not hold up.

“It drives people in industry crazy. Why are we seeing a collapse of the pharma and biotech industries? One possibility is that academia is not providing accurate findings,” he said.

BELIEVE IT OR NOT

Over the last two decades, the most promising route to new cancer drugs has been one pioneered by the discoverers of Gleevec, the Novartis drug that targets a form of leukemia, and Herceptin, Genentech’s breast-cancer drug. In each case, scientists discovered a genetic change that turned a normal cell into a malignant one. Those findings allowed them to develop a molecule that blocks the cancer-producing process.

This approach led to an explosion of claims of other potential “druggable” targets. Amgen tried to replicate the new papers before launching its own drug-discovery projects.

Scientists at Bayer did not have much more success. In a 2011 paper titled, “Believe it or not,” they analyzed in-house projects that built on “exciting published data” from basic science studies. “Often, key data could not be reproduced,” wrote Khusru Asadullah, vice president and head of target discovery at Bayer HealthCare in Berlin, and colleagues.

Of 47 cancer projects at Bayer during 2011, less than one-quarter could reproduce previously reported findings, despite the efforts of three or four scientists working full time for up to a year. Bayer dropped the projects.

Bayer and Amgen found that the prestige of a journal was no guarantee a paper would be solid. “The scientific community assumes that the claims in a preclinical study can be taken at face value,” Begley and Lee Ellis of MD Anderson Cancer Center wrote in Nature. It assumes, too, that “the main message of the paper can be relied on … Unfortunately, this is not always the case.”

When the Amgen replication team of about 100 scientists could not confirm reported results, they contacted the authors. Those who cooperated discussed what might account for the inability of Amgen to confirm the results. Some let Amgen borrow antibodies and other materials used in the original study or even repeat experiments under the original authors’ direction.

Some authors required the Amgen scientists sign a confidentiality agreement barring them from disclosing data at odds with the original findings. “The world will never know” which 47 studies — many of them highly cited — are apparently wrong, Begley said.

The most common response by the challenged scientists was: “you didn’t do it right.” Indeed, cancer biology is fiendishly complex, noted Phil Sharp, a cancer biologist and Nobel laureate at the Massachusetts Institute of Technology.

Even in the most rigorous studies, the results might be reproducible only in very specific conditions, Sharp explained: “A cancer cell might respond one way in one set of conditions and another way in different conditions. I think a lot of the variability can come from that.”

THE BEST STORY

Other scientists worry that something less innocuous explains the lack of reproducibility.

Part way through his project to reproduce promising studies, Begley met for breakfast at a cancer conference with the lead scientist of one of the problematic studies.

“We went through the paper line by line, figure by figure,” said Begley. “I explained that we re-did their experiment 50 times and never got their result. He said they’d done it six times and got this result once, but put it in the paper because it made the best story. It’s very disillusioning.”

Such selective publication is just one reason the scientific literature is peppered with incorrect results.

For one thing, basic science studies are rarely “blinded” the way clinical trials are. That is, researchers know which cell line or mouse got a treatment or had cancer. That can be a problem when data are subject to interpretation, as a researcher who is intellectually invested in a theory is more likely to interpret ambiguous evidence in its favor.

The problem goes beyond cancer.

On Tuesday, a committee of the National Academy of Sciences heard testimony that the number of scientific papers that had to be retracted increased more than tenfold over the last decade; the number of journal articles published rose only 44 percent.

Ferric Fang of the University of Washington, speaking to the panel, said he blamed a hypercompetitive academic environment that fosters poor science and even fraud, as too many researchers compete for diminishing funding.

“The surest ticket to getting a grant or job is getting published in a high-profile journal,” said Fang. “This is an unhealthy belief that can lead a scientist to engage in sensationalism and sometimes even dishonest behavior.”

The academic reward system discourages efforts to ensure a finding was not a fluke. Nor is there an incentive to verify someone else’s discovery. As recently as the late 1990s, most potential cancer-drug targets were backed by 100 to 200 publications. Now each may have fewer than half a dozen.

“If you can write it up and get it published you’re not even thinking of reproducibility,” said Ken Kaitin, director of the Tufts Center for the Study of Drug Development. “You make an observation and move on. There is no incentive to find out it was wrong.”

(Note: Amgen researcher C. Glenn Begley is not related to the author of this story, Sharon Begley)

(Reporting By Sharon Begley; Editing by Michele Gershberg and Maureen Bavdek)

Inside America’s Drug Shortage

Comments Off
Posted 23 Mar 2012 — by James Street
Category Big Pharma, Big Pharma, Cost, Finance and Politics of cancer research and treatment
The first in a two-part series investigating why critical prescription drugs are in short supply in the U.S.
By Alice Park | @aliceparkny | March 19, 2012

Lynn Divers thought she had heard the worst of it when doctors told her that her daughter Alyssa had cancer. But the diagnosis was only the first in a series of emotional bombshells: Alyssa’s cancer, osteosarcoma, is rare, and in her case, aggressive, requiring a cocktail of different chemotherapy drugs. She didn’t respond well to the first regimen that doctors tried, which led to their adding three other punishing medications to her treatment. Because of the chemotherapy, Alyssa’s kidneys were in danger of failing, so she would need nightly infusions of phosphorous to keep her organs functioning.

Then came the truly heartbreaking news. In late February, when Divers called the hospital to confirm Alyssa’s upcoming chemotherapy treatment, the nurse informed her that there was a drug shortage. The hospital couldn’t be sure that there would be enough methotrexate — the cornerstone of therapy for some childhood cancers, including leukemia and osteosarcoma — to treat Alyssa, now 10. Divers was told she might have to reschedule the session; the hospital would let her know. “It made me sick to my stomach to hear that,” says Divers, a former chaplain from Palmyra, Va. “Alyssa was in treatment for over a year already, and the last thing you want to do is add unnecessary delays in treatment, which gives the cancer a chance to catch up.”

Divers explains that her daughter’s cancer doubles in tumor load every 34 days, “so you need to hit it again and again to eradicate it.”

The story was much the same for Rebecca Robinson, 37, a historical interpreter from Sturbridge, Mass., when she showed up for chemotherapy at the Dana Farber Cancer Center in Boston in July. Robinson had been diagnosed with angiosarcoma, a rare, blood-based soft-tissue cancer, in February 2010, and she had already had five rounds of chemotherapy with Doxil, a drug that seemed to be keeping her cancer in check. When she showed up at the hospital expecting a sixth dose, however, her doctor told her that there was no more Doxil available. There were alternatives, but her physician wasn’t sure if the other drugs would work as well or if Robinson would have bad reactions to them.

“I was just in shock,” says Robinson. “How is it possible that no one knew this was coming? It just seemed impossible that a fairly commonly prescribed drug, especially in cancer treatments where it’s important for people to get the doses of their medicine regularly, could run out.”

For patients like Alyssa and Robinson, the questions — but no satisfactory answers — keep coming. How did this happen? How could hundreds, perhaps thousands of cancer patients suddenly find themselves without the drug treatments that could save their lives? The shortfalls have forced major cancer centers to stop putting new patients on either therapy; Dana Farber is adding only a limited number of new patients on Doxil treatment because physicians aren’t confident they can continue to provide the patients with enough of the drug to complete a full course of treatment.

In February, the U.S. government stepped in to resolve the critical cancer-drug shortages, allowing shipments of drugs from India and Australia to fill the gap. The immediate threat for many cancer patients had passed, but as Dr. Hagop Kantarjian, chairman of the leukemia department at M.D. Anderson Cancer Center in Houston, says, “All of these [efforts] are Band-Aids, temporary measures that don’t address the key issues.”

The shortfalls aren’t limited to cancer drugs either — antibiotics, anesthetics, vaccines and even medications to treat ADHD are getting scarcer. According to the Food and Drug Administration (FDA), demand outstripped the supply of 178 drugs in 2010. The University of Utah Drug Information Service, which works with the American Society of Health System Pharmacists (ASHP) to track shortfalls, says the number was actually closer to 211. Last year, the ASHP and Utah group say, the number of drugs in short supply reached a record high of 267.

What accounts for the widespread shortfalls? And why now? The FDA says 54% of the shortages in 2010 were due to manufacturing problems that led to temporary or permanent plant shutdowns. Drugmakers, while acknowledging that quality-control issues contribute to supply interruptions, point the finger back at the FDA. The agency is responsible for overseeing drug manufacturing safety and quality, but it lacks adequate funding to hire reviewers to look at companies’ applications for new manufacturing facilities and processes or to send inspectors to existing plants in a timely way. Its bureaucracy adds to delays in approvals for new facilities or manufacturing processes, which can run a year long; meanwhile, lags in new drug approvals also continue, leaving the drug supply in jeopardy.

Others cite the government’s tight price controls on generic drugs — particularly those paid for with Medicare and Medicaid — which slim down profit margins for manufacturers. Neither the government nor drugmakers subscribe to this explanation, but the argument goes that diminishing profits motivate drugmakers to abandon generics in pursuit of more profitable, patented products and de-incentivizes them from investing in better manufacturing technologies for generics. Both problems mean production of important drugs can grind to a halt when the slightest quality issue or financial glitch disrupts the system.

Congress has launched several investigations of the drug-shortage problem, and last year President Obama issued an Executive Order directing the FDA to expand its authority to police drug shortages, including requiring all manufacturers to notify the agency of impending shortages; currently the FDA can only compel companies to alert them if they are the sole maker of a drug they plan to discontinue.

The Obama Administration also instructed the FDA to report any violations of the government’s price controls on generics, which some critics believe will serve only to inflame the problem rather than resolve it.

Meanwhile, the nation’s drug supply is growing increasingly unstable, leaving an unprecedented number of patients vulnerable to lapses in care. “There’s little question that it has never been like this, not just with cancer drugs but with drug shortages in general,” says Dr. Michael Link, president of the American Society of Clinical Oncology. “We have had shortages before, but they have been intermittent, and never anything as extensive both in terms of the breadth of drugs affected and the depths of shortages and how long they lasted.”

So who’s right — the FDA or the industry? Or neither?

Follow the Money
“What’s driving the shortages is primarily the economics of drug supply,” says Kantarjian. “Anybody who tells you otherwise is not telling the truth.”

Kantarjian was directly affected by supply problems in December, when inventories of the chemotherapy drug cytarabine — a critical drug that can improve survival rates of patients with acute myeloid leukemia from 0% to 40% — began to shrink. When the shortfall was publicized, he and other cancer doctors soon received offers from distributors who appeared to have stockpiled stashes of the drug and were only too happy to sell them — for a price. They were asking $800 to $900 per gram for a medication that normally costs $16. “Nobody should profit from the lives of patients,” he says. “This price gouging is not illegal, but it is immoral.”

The distributors are not the real source of the drug shortage, however. They’re merely opportunists taking advantage of an unfortunate situation. Of the 178 drugs that the FDA reported in short supply in 2010, the majority were generics, meaning they don’t have patent protection and aren’t as profitable for the companies that make them. Many drugmakers say they are not letting their bottom line influence their focus on the manufacture of generic medications, but it’s hard to ignore the fact that the number of drug shortages has climbed in tandem with the number of generics on the market.

With cancer drugs, that’s not just coincidence, especially not after Congress changed the reimbursement scheme in 2005 for doctors administering chemo. To make chemotherapy treatments easier and more convenient for patients, doctors started offering the infusions in their own offices, instead of at a hospital, buying the drugs themselves and billing patients for them. In order to control escalating drug prices, the Medicare Modernization Act limited Medicare reimbursement to doctors to a 6% profit on these drugs, on top of the retail price of the medications. The problem was, the retail price reimbursed by Medicare lagged behind current market prices by about six months, which meant that reimbursements rates were lower than what doctors were paying to buy the drugs. That pushed some physicians to switch to offering their patients brand-name drugs, at higher prices.

The net effect? Fewer orders for generic drugs, which further shrank the market and lowered incentives for generic-drug makers to continue manufacturing such low-profit products. “In order to gain market share, companies underbid the market to get the business, and it’s a race to the bottom,” says Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society. “Whoever is the last company standing can’t charge enough to make a profit on the drug and to make needed investments to keep making the drug.”

That’s what may have happened with the methotrexate that Alyssa Divers depends on. Four domestic manufacturers produced the preservative-free injectable form of the drug: one company — Ben Venue Laboratories, one of the nation’s largest suppliers — decided to close its plant to make changes to satisfy the FDA after an inspection; another, which had 40% of the market share of the drug, lacked enough raw material to continue production; and a third company also started restricting its production. So by the beginning of the year, the supply of methotrexate had begun to plummet.

When Alyssa’s mother called her daughter’s nurse for a second time back in February, several days before her next scheduled infusion of methotrexate, the nurse still couldn’t assure her that Alyssa would get her dose. Even more worrisome for Divers was the fact that Alyssa already hasn’t responded to, or can’t tolerate, the side effects of two of the possible chemotherapy drugs that could fight her cancer. “If we can’t get methotrexate, that sends further terror into your heart,” she says.

Because the chemotherapy treatments have worn down Alyssa’s immune system, she has been hospitalized eight times for infections, and had a fracture in her leg that prevented her from walking for six months. “This kid has been through hell and back,” says Divers. “On top of everything else, to not have the medication she needs be available is devastating.”

Why Don’t Drug Shortages Happen in Other Countries?
The FDA maintains that price controls aren’t the problem and that its system for inspecting and certifying production facilities hasn’t changed. Rather, it’s the companies’ manufacturing issues that account for the majority of the drug shortfalls, the FDA says. Because most generics are older drugs that have been around for many years, they tend to be made in older facilities that have not kept up with the latest standards, making them more vulnerable to violations of FDA requirements. “The reality is that many of these facilities are getting older,” says Dr. Margaret Hamburg, the FDA’s commissioner. “These are not brand-new drugs and manufacturing facilities, so as the manufacturing facilities age, that creates new opportunities for quality and manufacturing concerns.”

The Generic Pharmaceutical Association (GPhA), however, says that in recent years, inspections have become harder to pass. “From the industry’s perspective, the FDA has been much more aggressive in their inspection formats over the past two to four years,” says David Gaugh, senior vice president for regulatory sciences at GPhA, who has had experience at a generic manufacturer.

Further, generic-drug makers say that once the FDA inspects a plant and leaves company officials with a list of items that don’t meet its specifications for quality and safety, the company has 15 days to respond with a plan to address the deficiencies. But the FDA does not always respond with a timely green light for the plan, leaving companies with difficult decisions to make about how much to invest in changes and whether to shut down production lines in the interim.

The good news is, that situation has been changing, and drugmakers say the FDA has recently become more open and communicative about efficiently addressing quality and manufacturing problems. But the ongoing buildup of shortages suggests that the problem goes deeper than sluggish communication during the inspection process.

Why, for example, are the shortages hitting certain kinds of drugs hardest, including those that have to be kept sterile and are made in injectable form? The FDA and drugmakers say it’s because these drugs are more complicated to make, and requirements for ensuring that they remain sterile, and free of any contaminants or foreign objects, are more stringent than they are for punching out pills.

Other observers point once again to the economics, noting that it costs more to manufacture sterile injectables — which include methotrexate and the flu vaccine — while their selling price remains relatively low. They also note that drug shortages are more common in the U.S. than in Europe or other countries, owing primarily to the smaller profit margin for generics here. In the U.K., for example, generic drugs often cost more than brand-name medications because the government health system is the primary purchaser of pharmaceuticals, and their negotiated price for brand drugs are far lower than they are in the U.S.

That also leads to the siphoning of generic drugs from the U.S. supply, which may also contribute to the shortfalls. “Because the profit margin is higher for generic drugs in Europe and outside the U.S., it’s rare to see a shortage in these drugs anywhere but here,” says Kantarjian.

Sylvia Bartel, vice president of pharmacy at Dana Farber, says, “I have never seen shortages like this before, especially for drugs that have been around for a really long time that we would not have thought were difficult to obtain. I think a lot of it does have to do with the economics around generics.”

The FDA is confident that it has resolved the immediate emergency around the shortages of methotrexate and Doxil (a brand-name medicine). But will it be enough?

Stay tuned for Part 2 of Healthland’s investigation into drug shortages: “Scrambling for a Solution”

House Votes to Scrap Medicare Payment Board

Comments Off
Posted 23 Mar 2012 — by James Street
Category Dog Osteosarcoma, Finance and Politics of cancer research and treatment

 

 

By Emily P. Walker, Washington Correspondent, MedPage TodayPublished: March 22, 2012

 

WASHINGTON — The House of Representatives has voted 223-181 to repeal the Independent Payment Advisory Board (IPAB) for Medicare, and to restrict medical malpractice lawsuits.

The measure is known as H.R. 5, the Protecting Access to Healthcare Act, and is sponsored by Rep. Phil Gingrey, MD (R-Ga.). It would eliminate the IPAB, the 15-member independent panel created under the Affordable Care Act (ACA).

Starting in 2015, the IPAB would be tasked with making binding recommendations on how to reduce Medicare spending. If Congress doesn’t agree with the recommended cuts, it would be required to pass its own cuts of the same size.

But Republicans, along with some Democrats, oppose the concept, saying it would lead to rationing of medical care. The Obama Administration has noted that under the law, the IPAB is prohibited from recommending changes to Medicare that ration health care, restrict benefits, modify eligibility, increase cost-sharing, or raise premiums or revenues.

Several prominent Democrats voiced support for the IPAB repeal earlier in the month, including Rep. Frank Pallone of New Jersey and Rep. Allyson Schwartz of Pennsylvania, who also authored legislation to repeal the sustainable growth rate (SGR) formula for physician reimbursement under Medicare. However, after House Republicans added a provision to the IPAB bill that limited the amounts of damages awarded in medical malpractice lawsuits to $250,000, Democratic support appeared to disappear.

Historically, Democrats (including President Obama) oppose caps on medical malpractice lawsuits. Republicans said the malpractice cap would discourage frivolous lawsuits against doctors and hospitals.

The American Medical Association (AMA), which supports the ACA as a whole but opposes the IPAB, praised the House vote.

“We applaud the House for voting to eliminate the IPAB, a panel which would have too little accountability and the power to make indiscriminate cuts that adversely affect access to health care for patients,” said Jeremy Lazarus, MD, president-elect of the AMA. “This new, arbitrary system is not what we need when patients and physicians are already struggling with a looming cut of nearly 30 percent from the broken Medicare physician payment formula.”

The group also spoke in favor of the medical malpractice provision of the bill.

However, the bill is likely dead on arrival in the Senate, and the White House threatened to veto the bill if it does pass the Senate. Obama has called the IPAB a crucial component for restraining the growing cost of Medicare.

Hope or Hype: The Obsession with Medical Advances and the High Cost of False Promises

Comments Off
Posted 19 Mar 2012 — by James Street
Category Big Pharma, Big Pharma, Books, Ethics of Science, FDA, Finance and Politics of cancer research and treatment

Book Description

Publication Date: January 15, 2005
“Medical science has always promised — and often delivered — a longer, better life. But as the pace of science accelerates, do our expectations become unreasonable, fueled by an industry bent on profits and a media desperate for big news? Hope or Hype is a taboo-shattering look at what drives the American obsession with medical “miracles,” exposing the equipment manufacturers and pharmaceutical companies; doctors and hospitals too quick to order surgery; the politicians; the press; and our own “technoconsumption” mindset. The authors spread blame for the parade of so-called miracle cures that too often are marginally effective at best — and sometimes downright dangerous. They examine consumers’ eager embrace of medical advances, and present riveting stories of the conscientious doctors and researchers who blew the whistle on ineffective treatments. Finally, they provide sane, practical recommendations for the adoption of new developments. The consequences of questionable practices include costly recalls, billions in wasted money, and the pain and suffering of innumerable patients and their families. In short, they must stop.”

From The New England Journal of Medicine

Armed with support from the Robert Wood Johnson Foundation, Deyo and Patrick make a well-documented — if depressing — argument that doctors, scientists, and laypersons alike are far too easily seduced by industry hype for merely new (as opposed to truly better) drugs and medical devices. Deyo and Patrick are appropriately tough on the Food and Drug Administration’s (FDA’s) drug approval process, in part because the agency’s mission does not include weighing one drug against another but, rather, merely approving a new drug if it works at all, even if it has no advantages over cheaper drugs already on the market. The authors are even tougher on the FDA’s process for approving medical devices, deftly hanging the agency by its own quotes, such as this gem: “New devices are less likely than drugs to have their safety established clinically before they are marketed.” And, of course, they note that it is not part of the FDA’s mission to regulate surgical procedures. But the basic message from Deyo and Patrick, both professors at the University of Washington, is that we are all too ready to believe that new, expensive, or aggressive care must be better than older, cheaper, or milder treatments. It is a cultural thing, they argue, citing one study that showed that whereas 34 percent of Americans believe that modern medicine can cure almost anything, only 27 percent of Canadians and 11 percent of Germans do. There is little that is new in this book for anyone who has followed the medical journals and the mainstream press over the past decade. But it is an excellent reference for the reader who wants details of the horror stories that have grabbed headlines: the rise and fall of the fenfluramine-phentermine diet pill (sometimes referred to as “fen-phen”); the high failure rate associated with some cardiac pacemakers; the widespread use of bone marrow transplantation for advanced breast cancer before studies finally showed that it was no more effective, and could be more dangerous, than standard chemotherapy; the appalling suppression or delayed publication of “negative” results in studies funded by drug makers. Citing example after example, Deyo and Patrick are at their most successful when they detail the degree to which the pharmaceutical industry, the most profitable industry in the United States, sometimes abuses its enormous power. Happily, just when you are about to move on to something, anything, else, Deyo and Patrick come up with a comparatively upbeat ending, exploring some remedies for America’s ills. They like the idea of having insurers pay provisionally for some new treatments so that the insurers could easily stop payment if a treatment proved worthless or dangerous. They like the idea, endorsed last September by a coalition of editors of medical journals, including this one, of a national registry for clinical trials in order to make it harder for the manufacturers of drugs and devices to suppress negative findings. They want to stop drug companies from claiming marketing expenses as tax deductions — a no-brainer, in my mind. And they want a better post-marketing surveillance system for drugs and devices. None of this will be easy. Fixing the mess, the authors conclude, will “require action by doctors, hospitals, the media, and the government.” Judy Foreman, Ed.M.

From Booklist

The authors, medical research academics, present their analysis of a phenomenon in American culture, which seeks state-of-the-art medicine regardless of the price. Avoiding controversial issues such as stem-cell research and abortion, theirs is an indictment of our health-care players, including the drug industry, device manufacturers, the media, the government, advocacy groups, hospitals, doctors, and patients. Deyo and Patrick recommend all parties change their behavior. Their concerns include aggressive marketing of new and costly products that contain only modest or no advantage over older alternatives, and doctors performing unnecessary operations. They focus upon whether and how new treatments sometimes become popular. They conclude that while fewer people in the U.S. can get insurance, people with insurance are getting a richer package of treatments although some of the technology they are buying is worthless. This is an important topic, and although many may argue with the authors’ views, they present an excellent framework for debate and discussion. Mary Whaley

Insight: Cheap generics no panacea for India’s poorest

Comments Off
Posted 19 Mar 2012 — by James Street
Category Ethics of Science, Finance and Politics of cancer research and treatment

By Henry Foy and Kaustubh Kulkarni

MUMBAI | Sun Mar 18, 2012 1:01am EDT

(Reuters) – Cheap generic drugs were meant to change the life of Nandakhu Nissar, whose mouth is swollen by a cancerous tumor. But the cashless and hungry 55-year-old sleeps on a pavement staring up at the windows of Mumbai’s biggest cancer hospital.

“What is a generic drug?” shrugs Nissar, who has travelled over 1,500 km (900 miles) from his home in the hope of treatment.

“I have borrowed money from friends and relatives and it is running out fast,” says Nissar, his pale eyes filling with tears.

A ruling this week that for the first time allowed an Indian drugmaker to make and sell a blockbuster cancer drug at a fraction of the market price has been hailed as a breakthrough by campaigners for cheaper medicine in the emerging economy.

The generic version of the drug, German drugmaker Bayer’s Nexavar, will be produced under what is known as a compulsory license, available to nations to issue in certain cases where life-saving treatments are unaffordable.

Yet no amount of compulsory licenses will help the millions of poor Indians suffering from diseases like cancer, because even the generic version of Nexavar will be priced beyond the reach of India’s poor, experts and medical professionals say.

Increased state spending on free and accessible healthcare and policies to extend insurance cover to its poorest citizens would be far more effective weapons.

“The government has to start taking cancer seriously. They haven’t done anything,” said Dr M. Krishnan Nair, an award-winning Indian oncologist. “Even at generic prices, the drugs are too expensive for the poor. They don’t get anything.”

India allocated 268 billion rupees ($5.4 billion) for healthcare in 2011-12, around a sixth the size of the defense budget. That represents 2.13 percent of total government spending, or $4.50 for each person in the country.

With around 40 percent of the population living below the poverty line, healthcare is an upper-middle-class luxury in much of India where spending in private clinics is four times the amount of that in government hospitals. The poorest would-be patients literally beg for treatment on the outside of a chronically underfunded and overstretched health system.

As chairman of a committee tasked with formulating India’s cancer strategy in the five years to 2012, Nair advocated 23 billion rupees ($460 million) for cancer control. Around $40 million was eventually spent, he says.

AFFORDABILITY

Last Monday, India granted its first ever compulsory license, allowing Natco Pharma to manufacture and sell Nexavar, a liver and kidney cancer drug, inside the country. It effectively ends Bayer’s exclusive rights to the drug in India.

Campaigners for cheaper access to drugs hailed the decision, which was taken after the country’s patent office said Bayer’s Nexavar was not “reasonably affordably priced”.

But the ruling has reignited fears amongst global drugmakers like Pfizer, GlaxoSmithKline and Novartis. They see huge potential in rapidly growing economies such as India but are wary of intellectual property protection.

Natco will retail Nexavar at 8,800 rupees ($180) for a monthly dose, a fraction of the 280,000 rupees ($5,600) Bayer’s version cost.

But medical experts say cheaper drugs are just one tiny part of India’s health deficit.

“The compulsory license system might not really work because poor people cannot even afford the discounted price,” said G. Balachandhran, former head of the National Pharmaceutical Pricing Authority (NPPA), India’s drug price watchdog regulator.

“Instead of dealing on a case-to-case basis, India needs to have a policy that will bring more and more people under medical cover … We need to increase the health insurance penetration, so that even poor people can afford treatment,” he added.

Only 15 percent of India’s 1.2 billion population is covered by health insurance, according to business lobby group the Federation of Indian Chambers Commerce & Industry, meaning even at a lower price, Nexavar will be out of reach for many.

Still, the head of Pfizer, the world’s largest drugmaker, told Reuters on March 12 that there were around 100 million people in India with “wealth equivalent to or greater than the average European or American, who don’t pay for innovation”.

Pravin Anand, managing partner at Indian law firm Anand and Anand believes that compulsory licenses should primarily be granted in the case of pandemics, suggesting that affordability is a tricky gauge of necessity.

“Affordability is not an absolute concept; therefore something that is affordable for one individual might not be so for others,” said Anand.

NEWSPAPERS FOR DRUGS

On the congested street in downtown Mumbai, scores of cancer sufferers sit, lie and sleep on the hard concrete pavement outside the Tata Memorial Hospital, clutching X-rays and medical documents and wait to be prescribed drugs they cannot afford.

“Look what has happened to my boy,” said 65-year-old Debiprasad Sharma, wiping his tears as he pointed to the large tumor on the side of his six-year-old grandson Prithvi’s neck.

“We don’t have insurance … and we have spent more than 6,000 rupees already, double our monthly income,” said Sharma, who had travelled from northern India to the Mumbai pavement.

“Hundreds of people come here every day. Whatever money we can collect is spent on their treatment. There is no help from the government,” says H.K. Savla, managing trustee of Jeevan Jyot Cancer Relief & Care Trust.

His charity, run from a cramped office around the corner from the hospital, collects and sells used newspapers and glass bottles to pay for drugs, medical supplies and food for the cancer sufferers who arrive from across the country with little or no money for treatment.

Savla, who has been working for cancer sufferers for 27 years, says he needs 1.5-2 million rupees ($30,000-$40,000) a month to provide basic services to the people who come to him for help. His budget stretches to just $3,000 a month.

Even if all of that money were spent on the generic version of Nexavar, it would buy enough for barely 16 sufferers.

Tata Memorial, which gets government and private funding, performs about 70,000 major and minor cancer surgeries every year and chemotherapy sessions for more than 300 patients a day.

Patients with oxygen tubes in their noses sleep on benches in the corridors and families huddle on the floor of the teeming waiting area for cancer patients. Upstairs the ward is filled to the brim. At night, many will go back to sleep on the roadside or to cheap dormitories that charge 50 rupees a night.

“Here, consultations are free. But drugs are expensive. And so is the cost of an overnight stay,” says Savla, as people queued for bowls of rice from his charity’s pot by the roadside.

“HUGE DEBT”

Natco expects to sell $5-$6 million worth of generic Nexavar a year, its finance chief has said, equivalent to around 2,500 people using the drug for a full 12 months.

India has around 2.5 million people living with cancer, or about one in every 500 people, according to government reports and medical organizations. That figure might be below the mark.

“This is a gross underestimation,” said Nair, who is the country’s only representative on the advisory committee for the World Health Organization’s Director General.

“Suppose someone in a rural area has cancer of the stomach,” Nair explained. “He will have pain for 2-3 months. He will try indigenous medicines. Finally he will die. No one will record his true cause of death.”

There is a growing focus among global healthcare campaigners on the burden in poor countries of non-communicable diseases (NCDs) – chronic diseases like cancer and heart disease that kill millions who would survive with Western-style treatment.

The scale of the problem is immense. More than 36 million people die every year from NCDs – 80 percent of them in poor nations where access to diagnosis and treatment is very limited, according to the World Health Organization.

United Nations (UN) Secretary-General Ban Ki-moon told a high-level UN meeting in New York on the subject last September: “NCDs hit the poor and vulnerable particularly hard and drive them deeper into poverty.”

India has joined Thailand as only the second country to grant a compulsory license for a cancer drug, and legal experts say compulsory licensing could follow for other expensive treatments, including the latest types of HIV/AIDS medicines.

A provision of the Indian Patents Act allows for a compulsory license to be awarded after three years of the grant of patent on drugs that are deemed to be too costly.

But in a country where around 65 percent of the population incur lifetime debts as a result of healthcare spending, according to the National Sample Survey Organization, cheap generics might not be the only answer.

“Forget about costly drugs,” says 48-year-old Hasmukh Shah, whose 5,000 rupee wage pales in comparison with the 250,000 rupees ($5,000) he needs to treat his cancer. “I cannot even afford cheap medicines now because I have piled up huge debt.”

($1 = 49.9 rupees)

(Additional by Ben Hirschler in LONDON; Editing by Mark Bendeich and Jonathan Thatcher)

Woman with brain tumor says she was kicked out of hospital for using medical marijuana

Comments Off
Posted 14 Mar 2012 — by James Street
Category Cannabis, Ethics of Physicians, Ethics of Science, Finance and Politics of cancer research and treatment, Legal

View more videos at: http://nbcbayarea.com.

By Cheryl Hurd, NBCBayArea.com

SAN FRANCISCO — A medical marijuana celebrity with a brain condition said a local hospital kicked her out after she attempted to use medical marijuana inside.

Angel Raich, who fought for the right to use medical cannabis in a case that went to the U.S. Supreme Court in 2004 and 2005, talked to us outside of UCSF Medical Center in San Francisco moments after she said they booted her out.

“The pharmacist says ‘you’re not allowed to have cannabis in this hospital,’” Raich said. “‘And if you’re gonna try to have cannabis in this hospital we’re going to call the feds.’”

Raich said she checked into the hospital Monday morning for doctor-ordered tests on her brain. She suffers from chronic pain and seizures from an inoperable brain tumor and doctors didn’t give her very long to live, she said.

“You’re basically saying if I stay it’s like giving me a death sentence ’cause I’d have to be without my cannabis,’” Raich said she told a hospital employee.

Raich said she had no choice but to leave the hospital.

“I’m in a state university hospital in the state of California,” Raich said. “I have the right to have the same medical care as any other patient does.”

UCSF Medical Center released the following statement:

“UCSF is a smoke-free campus and this includes medical marijuana. Several members of the media have asked if UCSF allows the use of a vaporized form of marijuana. It does not. Even a vaporized form of medical marijuana releases particles in the air that are damaging to the lung. Any particles from vapor and odor could have an impact on other patients and hospital employees.

Under federal and state law, a physician is at legal risk related to any activity that could be construed as prescribing medical marijuana to a patient.”

During our interview with Raich, she appeared to have a seizure. When the fire department and paramedics arrived, Raich refused to return to UCSF. Instead, they took her to St. Mary’s Hospital.

Cancer drug shortage threatens patients

Comments Off
Posted 14 Mar 2012 — by James Street
Category Chemotherapy, Finance and Politics of cancer research and treatment
By Julian Spector   |   February 27, 2012

A recent cancer drug shortage is threatening the prognosis of many pediatric cancer patients with acute lymphoblastic leukemia. Injectable preservative-free methotrexate, a drug that treats acute lymphoblastic leukemia as well as rheumatoid arthritis, has been in short supply since November, when a principle manufacturer—Ben Venue Laboratories in Bedford, Ohio—shut down production. Since then, care providers around the country have scrambled to stock up on the drug, which plays a key role in fighting leukemia, lymphoma and osteosarcoma. Patients at Duke University Hospital have not been affected so far, said Dr. Daniel Wechsler, chief of pediatric oncology and hematology at Duke Hospital and associate professor of pediatrics. The shortage, however, demonstrates continuing flaws in the system of cancer drug production and distribution, which have caused regular shortages in the past several years. “The thing that is different about methotrexate is that it is curative, and there is no substitute,” said Duke oncologist Dr. Louis Diehl. “Imagine telling a child that you simply don’t have the medicine that can cure them. You never want to do that.” The Food and Drug Administration expedited its review process and approved a new manufacturer—APP Pharmaceuticals—for a preservative-free methotrexate, according to a FDA press release Feb. 21. Methotrexate forms part of the drug regimen for treating acute lymphoblastic leukemia—the most common cancer found in children that accounts for one quarter of all pediatric cancer cases, Wechsler said. With the development of this and other drugs, the survival rates for acute lymphoblastic leukemia rose from 10 percent in the 1960s to approximately 85 percent currently. **Economic pressures** The effectiveness of the drug does not excuse it from the dictates of supply and demand among drug manufacturers. Of the approximately 1.7 million new cases of cancer diagnosed each year, only 12,000 to 15,000 of them involve children under 15 years of age, Wechsler noted. This limits the opportunity to profit from manufacturing pediatric cancer drugs. “Because of the relatively small number of pediatric cancer cases in this country, there is not a big economic incentive for drug companies to spend a lot of resources making drugs that affect a relatively small numbers of patients,” he said. Methotrexate is a generic drug with a limited number of American producers. This leads to supply problems if one of those manufacturers has to stop production, such as when the FDA finds manufacturing problems at a facility, said Paul Bush, chief pharmacy officer at Duke Hospital. If the remaining producers cannot increase production to make up for the deficit when another closes, then shortages may follow. Questions remain about what role the government should play in moderating pharmaceutical supply crunches. “The government should be involved in terms of regulating because you don’t want lousy products hurting patients,” Wechsler noted. “But can the government force a company to produce something?” One proposal is to create a government oversight body that would communicate with drug manufacturers and compel them to alert the body of imminent shortages or planned halts in production, Wechsler noted. With this information, the government could then offer incentives to drug companies to maintain safe levels of supply for American patients. “[The system] is flawed on a big level because for a given drug company, they’re under no obligation to say, ‘We’re stopping production of this drug in a month.’ And if they are the only one that makes it, we’re out of luck,” he said. “There’s no regulatory body that says every month, ‘You need to tell us what your supplies are and what your plans are.’ That would be the ideal.” Bush noted that proposed legislation compelling companies to report their supplies more frequently could help, but ultimately a market-driven solution is required. “It’s been a free market for years—the drug companies manufacture products that sell,” Bush said. “The better government can’t mandate that a company make a product. All they can do is provide some sort of incentive to make the product, like a tax break.” **Who gets what?** The recent drop in methotrexate supplies is only the latest in a series of 20 to 25 drug shortages that have required the Duke medical community make allocation priority decisions in the past 14 months, said Dr. Philip Rosoff, director of clinical ethics at Duke Hospital and professor of pediatrics and medicine. This has forced Duke Hospital to determine how to prioritize medical supplies in the event that they lack sufficient drugs to serve the patients in need. Rosoff led the deliberations of a committee of oncologists, pharmacists, ethicists and other relevant stakeholders Feb. 6 to apply the existing policy to the current preservative-free methotrexate shortage. “[We asked,] ‘who can benefit the most from the remaining stock?’” Rosoff recalled. “Let’s say we have 100 grams of methotrexate, and we have enough patients in those situations where it can be used for a cure, but cumulatively they need more than 100 grams. Which of those patients get it?” The committee came to a consensus that the top priority patients should be those for whom there is the greatest evidence of the drug’s efficacy, which in this case means children with acute lymphoblastic leukemia and certain types of bone cancer, he said. Next, priority goes to patients in the midst of treatment over those who have not started and then to patients for whom the drug is less likely to be effective. Within those bounds of comparable medical situations, Rosoff said, all patients are equal. “Patients are patients irrespective of other characteristics about them,” he noted. “There’s no VIPs that can jump ahead of people, and no less important people that we can bump to the back.” Although the policy is in place, there has not been cause to implement it yet at Duke. “We are lucky in that we [at Duke] have yet to have be faced with having to make a tragic choice between two or more people who could realistically benefit from receiving a scarce medicine when there is not enough to treat all of them,” Rosoff said. “But if we keep on having shortages like this, then this will come up some time.”

Physicians in Congress Committing Malpractice on Millions

Comments Off
Posted 13 Mar 2012 — by James Street
Category Big Pharma, Ethics of Physicians, Finance and Politics of cancer research and treatment
Friday 9 March 2012
by: Dr. Brian Moench, Truthout | News Analysis

The sun setting behind a thick layer of air polution. (Photo: D’Arcy Norman / Flickr)

What would you think if your physician told you, “Keep smoking because quitting would kill tobacco and health care jobs.” Or, “Don’t take your high blood pressure medicine, you can’t afford it.” And, “Don’t lose weight, no one has proven obesity is bad for you.”

That’s exactly the quality of medical advice we are getting from the 18 Republican physicians currently serving in Congress. Some of the most well known are the father and son team of Rep. Ron Paul and Sen. Rand Paul, and Sen. Tom Coburn. Almost all of these physician/Congressmen have been key soldiers in the Republican war on the Environmental Protection Agency (EPA), calling it a “job killer,” pronouncing relevant health science “unproven,” claiming we “can’t afford” their regulations.

In the last ten years, over 2,000 scientific studies published in the mainstream medical literature have revealed that air pollution has much of the same physiologic and disease consequence as first- and second-hand cigarette smoke.(1, 2) Those studies show that just as there is no safe number of cigarettes a person can smoke, there is no safe level of air pollution a person can breathe. Even pollution at “background” levels still causes health consequences, including increased mortality rates.(3, 4)

Air pollution contributes to and/or exacerbates, virtually every lung disease known, in every age group, from newborns to the elderly. The connection is as solid as that between smoking and lung cancer; in fact, air pollution also causes lung cancer. But air pollution damages much more than the lungs. It causes a systemic low-grade arterial inflammation,(5) impairing and increasing the disease potential of virtually every organ system, especially the heart, lungs, brain and placenta. Heart attacks, strokes, sudden death, poor birth outcomes, higher infant mortality rates, autism, Alzheimer’s, diabetes and breast cancer are just some of the many diseases found to occur in significantly higher rates among people who breathe more air pollution. Even people who are otherwise healthy are harmed. Air pollution accelerates the aging process, increases the average person’s blood pressure and shortens life expectancy even if it causes no obvious symptoms.(6, 7, 8, 9, 10)

Particulate air pollution, the primary focus of EPA regulations, can travel from the lungs to the arteries and eventually penetrate any cell in the body. For example, the chemicals and heavy metals within particulate pollution can actually penetrate brain tissue, causing loss of intelligence and memory and learning impairment in children.(11, 12, 13, 14, 15, 16)

Pollution particles can even penetrate subcellular structures like the cell nucleus where the all-important chromosomes lie. Particulate air pollution can alter and damage chromosomes, especially serious if occurring during early embryonic development. By causing chromosomal dysfunction, air pollution can even impair the health of future generations.(17, 18, 19, 20, 21)

The nation’s premier pollution and health experts, the Clean Air Scientific Advisory Committee (CASAC) regularly review all new medical research and advise the EPA on updating the national air pollution standards. Every time the CASAC has made that review, they have called for making those standards more strict, as they are doing right now and have been since 2006.

Supporting the CASAC in calling for standards even stricter than what Republicans are bludgeoning the EPA for, is virtually every major medical and public health organization in the country, specifically, the American Medical Association, the American Thoracic Society, the American Lung Association, the American Academy of Pediatrics, the American College of Cardiology, the American Heart Association, the American Cancer Society, the American Public Health Association and the National Association of Local Boards of Health. Indeed, there is no reputable health group that disagrees with the CASAC’s recommendations.(22, 23) because they understand and accept new research, apparently unlike our physician/Congressmen.

Every study not funded by fossil fuel industries has shown economic and health benefits of controlling air pollution far exceeding the costs of implementing those controls, even if pollution levels are already low. In fact, the benefits average 30 times greater than the costs, and those benefits create jobs, not kill them.(24) That kind of rate of return on investment should be impressive, even to someone who works for Bain Capital. (By the way, someone should tell Mitt Romney, he could do a leveraged buy out of the EPA.)

Being on the front lines of patient care, in a specialty where the margins between life and death can be very thin, I’m reluctant to accuse other physicians of malpractice. However, it is obvious these lawmakers have let political fealty co-opt their medical judgment. Moreover, their malfeasance has the potential to sabotage the health of millions, not just a handful of their own patients. This is malpractice on a grand scale.

Footnotes:

1. Peters, A. “Air Quality and Cardiovascular Health: Smoke and Pollution Matter,” Circulation. 2009: 120:924-927

2. Eugenia E. Calle and Michael J. Thun C. Arden Pope, III, Richard T. Burnett, Daniel Krewski, Michael Jerrett, Yuanli Shi. Circulation. 2009; 120:941-948. “Cardiovascular Mortality and Exposure to Airbourne Fine Particulate Matter and Cigarette Smoke.”

3. Elliott CT, Copes R. “Burden of mortality due to ambient fine particulate air pollution.” (PM2.5) in interior and Northern BC. Can J Public Health. 2011 September-October;102 (5):390-3.

4. Peters, A, and Pope, CA III Editorial, Lancet. Vol 360, Oct 19, 2002.

5. American College of Cardiology.(2008, August 14) “Air Pollution Damages More Than Lungs: Heart And Blood Vessels Suffer Too.”

6. Urch B, Silverman F, Corey P, Brook J, Lukic K, Rajagopalan S, Brook R. “Acute Blood Pressure Responses in Healthy Adults During Controlled Air Pollution Exposures.” Environ Health Perspect. 2005 August; 113 (8): 1052–1055.

7. Sérgio Chiarelli P, Amador Pereira LA, Nascimento Saldiva PH, Ferreira Filho C, Bueno Garcia ML, Ferreira Braga AL, Conceição Martins L. “The association between air pollution and blood pressure in traffic controllers in Santo André, São Paulo, Brazil.” Environ Res. 2011 May 11. (Epub ahead of print.)

8. Brook RD, Shin HH, Bard RL, Burnett RT, Vette A, Croghan C, Thornburg J, Rodes C, Williams R. “Exploration of the rapid effects of personal fine particulate matter exposure on arterial hemodynamics and vascular function during the same day.” Environ Health Perspect. 2011 May;119 (5):688-94.

9. Adar SD, Klein R, Klein BE, Szpiro AA, Cotch MF, Wong TY, O’Neill MS, Shrager S, Barr RG, Siscovick DS, Daviglus ML, Sampson PD, Kaufman JD. “Air Pollution and the Microvasculature: A Cross-Sectional Assessment of In Vivo Retinal Images in the Population-Based Multi-Ethnic Study of Atherosclerosis (MESA)” PLoS Med. 2010 November 30;7 (11):e1000372.

10. Pope, CA III, Ezzate, M., Dockery, D. “Fine-Particulate Air Pollution and Life Expectancy in the United States.” NEJM. Vol. 360:376-386 January 22, 2009, Num. 4.

11. Calderon-Garciduenas, L. et al. (2002) “Air pollution and brain damage.” Toxicol. Pathol. 30, 373–389

12. Calderon-Garciduenas, L. et al. (2003) “DNA damage in nasal and brain tissues of canines exposed to air pollutants is associated with evidence of chronic brain inflammation and neurodegeneration.” Toxicol. Pathol. 31, 524–538 .

13. Mateen F, Brook R. “Air Pollution as an Emerging Global Risk Factor for Stroke,” JAMA. 2011;305 (12):1240-1241.doi:10.1001/jama.2011.352.

14. Morgan TE, Davis DA, Iwata N, Tanner JA, Snyder D, Ning Z, et al. 2011. “Glutamatergic Neurons in Rodent Models Respond to Nanoscale Particulate Urban Air Pollutants In Vivo and In Vitro.” Environ Health Perspect : doi:10.1289/ehp.1002973.

15. Gackière F, Saliba L, Baude A, Bosler O, Strube C. “Ozone inhalation activates stress-responsive regions of the central nervous system.” J Neurochem. 2011 April 6. doi: 10.1111/j.1471-4159.2011.07267.x. (Epub ahead of print.)

16. Calderón-Garcidueñas L, D’Angiulli A, Kulesza RJ, Torres-Jardón R, Osnaya N, Romero L, Keefe S, Herritt L, Brooks DM, Avila-Ramirez J, Delgado-Chávez R, Medina-Cortina H, González-González LO. “Air pollution is associated with brainstem auditory nuclei pathology and delayed brainstem auditory evoked potentials.” Int J Dev Neurosci. 2011 March 31. (Epub ahead of print.)

17. Bocskay K, Tang D, Orjuela M, et al. “Chromosomal Aberrations in Cord Blood Are Associated with Prenatal Exposure to Carcinogenic Polycyclic Aromatic Hydrocarbons.” Cancer Epidem Biomarkers and Prev. Vol. 14, 506-511, February 2005.

18. Perera F, Tang D, Tu Y, “Biomarkers in Maternal and Newborn Blood Indicate Heightened Fetal Susceptibility to Procarcinogenic DNA Damage.” Environ Health Persp Vol 112 Number 10 July 2004.

19. Pilsner JR, Hu H, Ettinger A, Sanchez BN, et al. “Influence of prenatal lead exposure on genomic methaylation of cord blood DNA.” Environ Health Persp, April 2009.

20. Baccarelli A. “Breathe deeply into your genes!: genetic variants and air pollution effects,” Am J Respir Crit Care Med. 2009 March 15;179 (6):431-2.

21. Baccarelli A, Wright RO, Bollati V, Tarantini L, Litonjua AA, Suh HH, Zanobetti A, Sparrow D, Vokonas PS, Schwartz J. “Rapid DNA methylation changes after exposure to traffic particles.” Am J Respir Crit Care Med. 2009 April 1; 179 (7):523-4.

22. Letter from the CASAC to EPA Administrator Stephen L. Johnson, September 29, 2006.

23. Letter from 1,882 physicians and health care professionals to Congress, February 9, 2011.

24. EPA report “The Benefits and Costs of the Clean Air Act: 1990 to 2020.”

Cancer Community Leaders Make Case for Federal Funding to Deliver Promising Local Research from Labs to Doctors’ Offices

Comments Off
Posted 25 Feb 2012 — by James Street
Category FDA, Finance and Politics of cancer research and treatment, General Cancer Research, NIH

By American Cancer Society Cancer Action Network (ACS CAN)

Posted: 1:15pm on Feb 23, 2012; Modified: 1:19pm on Feb 23, 2012

Read more here: http://www.bradenton.com/2012/02/23/3896977/cancer-community-leaders-make.html#storylink=cpy

 

SEATTLE, Feb. 23, 2012 — With the National Cancer Institute Facing Budget Cuts, Washington Cancer Community Urges Congress to Make Research Funding a Priority

SEATTLE, Feb. 23, 2012 /PRNewswire-USNewswire/ — The American Cancer Society Cancer Action Network (ACS CAN) brought cancer community leaders together at the Fred Hutchinson Cancer Research Center today to encourage lawmakers to support increased federal funding for cancer research so that progress can continue against a disease that kills an estimated 1,500 people in America each day.

“We are on the verge of making unprecedented progress that could change the way we prevent and treat cancer in this country, thanks in no small part to previous federal investments in cancer research,” said Chris Hansen, president, ACS CAN, the advocacy affiliate of the American Cancer Society. “Any funding cuts to the National Institutes of Health will jeopardize the innovative research at local cancer centers that has resulted in the dramatic progress we have seen during the past 40 years against cancer.”

Earlier this month, President Obama’s Fiscal Year 2013 budget proposal included cuts for research funding at the National Cancer Institute at the National Institutes of Health (NIH) and for prevention programs at the Centers for Disease Control and Prevention. Congress is now beginning consideration of a budget resolution to establish funding levels for next year.

More than 80 percent of federal funding for NIH is spent on biomedical research projects at local research facilities across the country. According to NIH, nearly $24 billion funded nearly 51,000 research grants in every state and virtually every congressional district across the country last year alone. In 2011, research institutions in Washington received more than 1,574 grants totaling nearly $926 million in federal funding from NIH.

To highlight the impact of federal funding in Washington, Lawrence Corey, M.D., president and director of Fred Hutchinson Cancer Research Center, discussed examples of groundbreaking projects at the Center that currently receive funding from NIH.

“We at Fred Hutchinson Cancer Research Center are delivering on our mission to eliminate cancer as a cause of human suffering and death. Our pioneering research in bone marrow and stem cell transplantation has boosted survival rates for certain leukemias from nearly zero to 90 percent. Fewer women will face a diagnosis of cervical cancer thanks to our fundamental work in the development of Gardasil, a vaccine against the viruses that cause the majority of cervical cancers. The Hutchinson Center also played a key role in a Women’s Health Initiative study that found a link between combination hormone replacement therapy use and increased risk of breast cancer. This information significantly changed hormone-therapy use in the U.S. and, as a result, breast cancer rates among American women have declined by about 10 percent – that’s 20,000 fewer cases of breast cancer each year,” Corey said. “With sustained levels of federal research funding we must and will continue to build on these successes to seek ways to prevent cancer, detect the disease early and treat patients with targeted, less-toxic and less-invasive therapies.”

It takes nearly two decades on average to deliver a new drug or treatment from the lab to the doctor’s office for patient use. Cancer centers across the country depend on federal grants from agencies such as NIH as their largest source of cancer research funding. The Hutchinson Center, for example, relied on nearly $240 million in federal grants and contracts from NIH last year.

Corey was joined by lymphoma specialist Oliver W. Press, M.D., Ph.D., a member of the Hutchinson Center’s Clinical Research Division. For more than 25 years, Press and his colleagues have developed a highly effective way to spare normal cells while blasting cancer with high doses of radiation. Combined with stem-cell transplantation, this approach has produced some of the best lymphoma cure rates in the world. In his lab, Press’ newest therapeutic approach for leukemia and lymphoma shows great promise, with 100 percent cure rates so far in model organisms.

“Federal support of cancer research has put us on the verge of some incredible breakthroughs, and this work is going on here at Fred Hutchinson Cancer Research Center and other research institutions around the country. We need to bring these potential discoveries to fruition because they will lead to treatments for some of the most deadly cancers,” said Hansen. “I am convinced that Members of Congress will support funding when they understand this research is benefiting their own constituents, and is being conducted right in their own backyard.”

Federally funded research has a positive economic impact on communities nationwide. In 2010, NIH grants yielded $68 billion in new economic activity and supported 487,000 jobs across 50 states and Washington, D.C. In Washington, that investment translated into more than $1 billion in economic activity and more nearly 17,000 new jobs.

Seattle is the fifth largest biotech center in the country and 17,500 of its citizens are employed in the industry. One in five jobs in Seattle are tied to the health care sector overall. For every new position created at the Hutchinson Center 1.53 new jobs are created in Seattle.

Federal funding for medical research and cancer prevention programs has had a role in every major advance against this disease, resulting in 350 more lives saved from the disease per day than in 1991. Past federal investments have also put the scientific community on the verge of making groundbreaking new discoveries that could accelerate our progress and bring us closer to ending death and suffering from cancer.

About ACS CANACS CAN, the nonprofit, nonpartisan advocacy affiliate of the American Cancer Society, supports evidence-based policy and legislative solutions designed to eliminate cancer as a major health problem. ACS CAN works to encourage elected officials and candidates to make cancer a top national priority. ACS CAN gives ordinary people extraordinary power to fight cancer with the training and tools they need to make their voices heard. For more information, visit www.acscan.org.

About the Fred Hutchinson Cancer Research CenterAt Fred Hutchinson Cancer Research Center, interdisciplinary teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Hutchinson Center researchers, including three Nobel laureates, bring a relentless pursuit and passion for health, knowledge and hope to their work and to the world. For more information, please visit www.fhcrc.org.

SOURCE American Cancer Society Cancer Action Network (ACS CAN)

Read more here: http://www.bradenton.com/2012/02/23/3896977/cancer-community-leaders-make.html#storylink=cpy
← Previous Entries
Next Entries →