Latest Drugwonks' Blog
There is a growing awareness that science of attacking cancer is reaching a critical mass and is producing a truly transformational approach to treatment: one that re-engineers our natural immune responses to do the job of not just killing cancer cells but teaches the remaining ones to start become healthy.
There is a growing awareness that the way insurers have shifted cost to patients is discriminatory and that the claim that it’s a reaction to high prices is bogus.
There is a growing recognition that the value new medicines yield must be measured in terms of every month of every life gained. More people are alive today because each era of treatments keeps people alive longer for the next generation of therapies that improve and lengthen life even more.
And there is a growing recognition that the pace of progress is too damn slow, too dependent on outdate scientific methods that require people dying of disease to be randomized to different treatments or different combinations of treatments in ways that have little to do with their unique and increasingly accessible biological differences.
There is an increasing emphasis on improving the quality of life and the fact being treated for cancer does not mean being treated like a victim.
And finally, people are increasingly aware that by sharing information more quickly about the real world experience with medicines is the most scientific and efficient way to cure cancer.
I am honored to be part of this courageous community of advocates, patients, scientists and biopharmaceutical companies that express their awareness with growing discontent with the status quo. As Thomas Edison said: “Discontent is the first necessity of progress.”
At the same time that regulators in France, Germany, Belgium and Luxembourg are suspending the marketing approval of 25 generic drugs due to concerns over the quality of data from clinical trials conducted by India's GVK Biosciences, another Indian firm, Zydus Cadila, has launched a biosimilar of Adalimumab (an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including rheumatoid arthritis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis.)
Bad timing and, perhaps, bad science.
The quality of Indian pharmaceuticals has come under fire this year, with regulators in Europe and the United States citing problems ranging from data manipulation to sanitation and banning the import of certain products from several firms. And, it should be noted, these violations are for generic drugs, not biosimilars.
French and German regulators are investigating drug approvals based on clinical trials meant to show that these generic drugs were equivalent to the original branded versions conducted by GVK Bio between 2008 and 2014.
A Zydus Cadila spokesman commented that, “This therapy will offer a new lease of life to millions in India who have not had access to this therapy so far.” But the reality is that their product is more likely to be aggressively marketed for export.
Most importantly is the question of quality – or lack thereof. As company’s ranging from biotech innovator Amgen to multinational generics manufacturer Sandoz struggle to fulfill the clinical requirements for an Adalimumab biosimilar, two obvious questions arise -- (1) What does Zydus Cadila know that large multinational manufacturers don’t; and (2) What do Indian regulators know that their counterparts in the US and the EU are struggling to understand?
To not aggressively ask these questions is to bury one’s head in the sand.
And here’s an even tougher question -- In order to boost pharmaceutical exports, are Indian regulators willing to license substandard products?
According to a May 2012 article in The Lancet,
“To say that India's drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO)-whose remit includes new drug approval, licensing of manufacturing facilities, and regulation of drug trials-is not fit for purpose seems a gross understatement.”
“If I have to follow U.S. standards in inspecting facilities supplying to the Indian market,” G. N. Singh, India’s top drug regulator, said in an interview with an Indian newspaper, “we will have to shut almost all of those.”
Does that mean US standards are too high or that Indian ones are too low? Well, where you stand depends on where you sit. And if you’re sober and sitting up straight, the answer is obvious.
According to Dilip Shah, Secretary General of the Indian Pharmaceutical Alliance, some Indian manufacturers “doctor their data.” The solution? “Regulators should have regular liaison with manufacturers in India and China to explain to them how GMP works and that they don’t have to cheat.”
Feel better now?
The bad news is that Missouri is the only state that does not have a prescription drug monitoring program.
According to the New York Times, Missouri is the only state in America that has declined to keep a prescription drug database — the primary tool the other 49 states use to identify people who acquire excess prescriptions for addictive painkillers and tranquilizers, as well as the physicians who overprescribe them … Not having the database has not only hampered Missouri’s ability to combat prescription drug abuse, but also attracted people from neighboring states looking to stockpile pills and bring them home to take themselves or sell to others, according to law enforcement officials, legislators and data compiled by a prescription drug processing firm.
“Welcome to Missouri — America’s Drugstore,” said Dr. Douglas Char, an emergency room physician in St. Louis. “We aren’t just allowing abuse, we’ve created a business model for dealers.”
The good news is that Republican State Representative Holly Rehder is drafting a bill to change that.
The prescription drug-monitoring program (PDMP) is a database that collects information to let doctors and pharmacists lets doctors and pharmacists know a patient's prescription history. The program is used to reduce the amount of medications that are sold on the street and to reduce the risk of doctor shopping and abusing painkillers for nonmedical reasons.
One of the reasons the Show Me State has remained the Don't Show me State are unfounded concerns over privacy and Big Brotherism. Rehder’s proposed program would allow for only doctors and pharmacists to obtain the information and police officers would have to obtain a warrant to access the information.
Bob Twillman from the American Academy of Pain Management said the program helps identify not only if people are abusing drugs, but identifying their addiction so they can get professional help.
The bill previously passed in the House but has run into some roadblocks in the Senate, including St. Joseph Senator Rob Schaaf, who said the database would violate the privacy of citizens. After successfully sinking a 2012 version of the bill, Mr. Schaaf said of drug abusers, “If they overdose and kill themselves, it just removes them from the gene pool.”
Really?
Rehder said she is willing to work with Schaaf and others in order to get the bill passed.
Holly – don’t go lightly.
ACA should allow prescription drugs
President Barack Obama is fully vested in the claim that his Affordable Care Act is a success.
During a recent news conference, he pointed to the supposedly salutary effect the ACA has had on mitigating rising health care costs. "Health care inflation has gone down every single year since the law passed, so that we now have the lowest increase in health care costs in 50 years," Obama said.
Obama is right that health care inflation has slowed. The Centers for Medicare and Medicaid Services have reported exactly that for the past several years. But his praise is misplaced. Thanks is not due to the ACA but rather to increased access to prescription drugs, which help folks manage illnesses and stay out of the hospital. The ACA actually threatens to increase health care spending by keeping these vital prescription drugs out of reach for many Americans.
If policymakers are serious about slowing runaway health care costs, they need to ensure that sick people have good access to prescription medicines that will make them better.
Consider the example of Medicare Part D. In 2006, Medicare Part D expanded access and reduced the costs of prescription drugs for millions of Americans. The following year, prescriptions filled by Medicare beneficiaries jumped by 14 percent, and, as a result, the annual growth in spending per beneficiary dropped by almost half.
A new National Bureau of Economic Research study credited Part D coverage with an 8 percent drop in hospital admissions for seniors and around $1.5 billion in reduced hospital spending.
The Congressional Budget Office reached a similar conclusion in 2012, finding that spending on medical services dropped by 0.2 percent for every 1 percent increase in prescriptions filled.
In fact, failure to regularly take prescribed medications puts considerable strain on the health care system. A study from the Annals of Internal Medicine estimates that non-adherence already costs the health care system $100 billion to $289 billion a year. That includes avoidable hospitalizations, nursing home admissions and premature deaths.
Given the power of prescription drugs, the Obama administration should be pushing to increase their accessibility. Instead, the administration is actively working against them.
Since Medicare Part D began, the government has required insurers to cover drugs in six treatment areas. The Obama administration, however, proposed early this year to limit coverage of immunosuppressants, antidepressants and antipsychotic medicines for diseases like schizophrenia. The proposal caused an outcry from patients, health care providers and members of both political parties, and the administration scrapped the plan.
But now the Obama administration is doing damage elsewhere — by limiting prescription drugs through the health care exchanges created by the ACA.
Plans available through the exchanges often charge patients significant out-of-pocket fees to access needed prescription drugs. For moderate to low-income patients, these high costs may force them to miss prescriptions.
Insurance companies decide how to share costs with patients by using a tiered system. A patient who needs a drug in the lowest tier might have to pay only a $15 copay. But for those drugs in the highest tier, patients can pay as much as 40 percent of the actual cost of the drug, which can run up to tens of thousands of dollars.
Too many key medications on too many plans are now listed in the highest tier. A recent study from Avalere Health found that more than a fifth of all "Silver" Plans — the most popular coverage — require patients to pay 40 percent of the costs associated with seven classes of drugs. And 60 percent of Silver Plans placed all drugs for multiple sclerosis and rheumatoid arthritis on the highest cost-sharing level.
Just as expanded access to drugs reduces overall health care spending, restricting access drives up costs. Patients who can't readily afford to spend thousands of dollars on, say, their AIDS medication, will probably end up skipping doses. This non-adherence will increase hospitalization rates and overall health care spending.
If the Obama administration wants to put a brake on health care spending, it must preserve robust access to prescription drugs. The White House's attempts to limit prescription drug access in Medicare Part D are incredibly shortsighted. Instead, the administration should be doing all it can to ensure that more Americans have access to these vital drugs.
Peter J. Pitts, a former Food and Drug Administration associate commissioner, is president of the Center for Medicine in the Public Interest.
Here's a snapshot of what the impact HIV would have today on hospitalization, hospital costs and hospital deaths if we had listened to the naysayers. Data for chart below is from Agency for Healthcare Research and Quality (AHRQ), based on data collected by individual States and provided to AHRQ by the States for the Clinical Classification Code for HIV
Eleven of the 12 cancer drugs the Food and Drug Administration approved for fighting cancer in 2012 were priced at more than $100,000 per year, double the average annual household income, according to a report by the Journal of National Cancer Institute.
Those claims are inaccurate at best and lies at worst.
First, as a Milliman study showss, the average cost of chemotherapy is about $25000. A far cry from the $120K Kantarjian and Bacn assert.
And while most of the new targeted cancer drugs are expensive, the average price -- including a standard discount and not counting any patient assistance -- is $5000 a month.
The fact is, cancer drugs, as a percentage of what people spend, of cancer care and total health care spending is small.
An HHS study shows that prescription drugs, on average, cost people with cancer about $800 a year.
Kantarjian and others claim cancer drug prices cause bankruptcy. Also misleading. Cancer patients filing for bankruptcy comprise 2.2 percent of total filings. That's about 36,000 people a year. The vast majority are low income and are unemployed. That is a financially crushing combination for many more cancer patients beyond those who file for bankruptcy. But drug prices are not to blame.
It is true that many more people are paying thousdands for cancer drugs but as my next blog reveals the Kantarjians and Bachs of the world deliberately ignore the role insurance comapne play in turning life saving drugs into a finanially sickening challenges. More on that in my next post.
This Sunday, the Boston Globe asked, “Has health care improved with reclassification of hydrocodone?”
Here’s the response of the dynamic Cindy Steinberg, policy chair for the Massachusetts Pain Initiative and national director of policy and advocacy for the US Pain Foundation:
No.
Severely restricting access to the most commonly used and highly effective pain medication is unjustly punishing the millions of law-abiding citizens who struggle to live with pain every day while doing little to solve the problem of abuse and addiction.
Hydrocodone combination products are effective for both acute and chronic pain and are useful and appropriate for a wide range of painful conditions and diseases. They have relatively few side effects and have been shown to have lower abuse potential than single entity opioids. In 2011, approximately 47 million Americans used hydrocodone analgesics for pain relief.
The number of Americans now living with pain is staggering. The Institute of Medicine has documented that there are more than 100 million living with chronic pain in this country. Ten million Americans live with chronic pain so severe that it has disabled them, and this number is expected to increase as the population ages.
When prescribed to individuals with pain severe enough to require these medications, the incidence of abuse and addiction is extremely low. For many with chronic pain, these medications mean the difference between a life worth living or not.
The new rules took effect Oct. 6. They require patients to obtain an original hard copy prescription for every 30 days of their medication — necessitating many more doctor visits — and then hand-delivering the script to their pharmacy. Doctors can no longer call in, fax, or electronically submit these prescriptions. Refills are prohibited.
According to Rebecca Fortelka, who suffers from cerebral palsy and several other chronic pain conditions writing in the Nov. 18 National Pain Report, hydrocodone combinations are one of the only pain medications she can tolerate. Soon after the new rules went into effect, she contacted her doctor’s office as she was running out of her medicine and needed a renewal. “My pain was spiraling out of control as I was rationing meds to prevent being out of them,” she wrote. It took her doctor’s office four weeks to get the hard copy prescription ready, leaving her to suffer.
Cutting off the supply of pain medication will not solve abuse and addiction. Those who are predisposed to the disease of addiction will turn to other medications or illicit substances, leaving those with the disease of chronic pain with fewer options. People with addiction disorders need better treatment for the disease of addiction, coordinated follow-up, and continuing support.
Recent critics of cancer drug prices claim that the new higher priced medications drive up total health care spending.
In fact, the opposite is the case. The evidence is overwhelming. In fact, the addition of new medicines under Medicare's drug plan (Part D) has led to an absoute reduction in what's been spent on Medicare overall, $380 billion less to be exact. A recent Health Affairs blog notes: "Much attention in particular has focused on the remarkable slowdown in Medicare spending over the past few years, and rightfully so: Spending per beneficiary actually shrank (!) by one percent this year (or grew only one percent if one removes the effects of temporary policy changes).
Yet the disproportionate role played by prescription drug spending (or Part D) has seemingly escaped notice. Despite constituting barely more than 10 percent of Medicare spending, our analysis shows that Part D has accounted for over 60 percent of the slowdown in Medicare benefits since 2011 (beyond the sequestration contained in the 2011 Budget Control Act)."
Critics will respond that the decline in Medicare spending was a function of the recession. Not true. "The recession and its aftermath appear to have had little effect on Medicare Part A and Part B spending; senior’s incomes are less influenced by economic downturns and the large majority of beneficiaries have supplemental coverage that shields them from most Part A and Part B cost-sharing. The primary analysis on the topic from CBO, in fact, found that only one-eighth of the slowdown in Parts A and B from 2007-2010 could be explained by factors related to the economy – and not through the usual channel of utilization impacts that take place in the private market."
Finally, some argue that the decline in spending was due to increased use of generic drugs on the part of Medicare consumers. In fact, most of the increase in Part D spending is the result of the use of new medicines for cancer, MS, diabetes and other drugs for the most expensive conditions Medicare patients deal with. This is in line with studies conducted by Frank Lichtenberg and others showing that each dollar spent on new medicines reduces what would be spent on hospitals, doctors, etc. by $6.
Looking at the price of a new medicine or what we spend on biopharmaceuticals in isolation is misleading. Use of innovative medicines should be looked at in terms of the impact it has on other medical spending and the lives of patients.
Source: World Health Organization National Health Account database (see http://apps.who.int/nha/database/DataExplorerRegime.aspx for the most recent updates).
According to a story in the Austin Statesman, Federal law doesn’t deliver HIV care as promised.” The ACA, per the story, “brought a lot of hope … but the law didn’t live up to expectations” because … “the plans on the federally created health insurance exchange, the Internet-based marketplace where consumers can compare and buy health plans, didn’t offer affordable ways to buy the life-saving medications” or allow patients to see “physician with expertise in HIV and AIDS.
Carl Schmid, the deputy executive director at the David Powell Clinic AIDS Institute, blamed insurance companies that offer plans that he said discriminate against HIV and AIDS patients and require huge out-of-pocket payments for their expensive medications.
“They are designing their benefits in such a way to dissuade people with HIV and other conditions from choosing their plans,” he said, “and that’s against the law.” Schmid’s national public policy group filed a complaint with the Office of Civil Rights in the U.S. Department of Health and Human Services. The case is pending.
David Wright, one of the first physicians in Central Texas to treat AIDS patients, said, “For a lot of patients, it actually created more barriers. It’s kind of overwhelming.”
Peter Pitts, a former U.S. Food and Drug Administration official and current president of the Center for Medicine in the Public Interest, echoed Wright’s assessment. He said before the law’s rollout, the standard talking point of proponents was that people shouldn’t have to choose between food or medicine.
“Unfortunately not only did the ACA not solve that problem, it made it worse,” Pitts said. “That’s shameful.”
The complete story can be found here.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
