Here's part of PhRMA's press release which was edited out:PhRMA Defends Distribution of Pharmaceutical Samples;
New Study Fatally Flawed, 2003 Figures OutdatedWashington, D.C. (January 3, 2008) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement regarding the Jan. 2 American Journal of Public Health study on distribution of free pharmaceutical samples:
“Distribution of free samples by technically-trained pharmaceutical research company representatives – many of whom are healthcare professionals themselves – plays a critical role in improving patient care and fostering the appropriate use of medicines. Providing physicians with free samples of pharmaceuticals clearly benefits patients and advances healthcare throughout the United States.
So free samples improve patient care? Those research company reps who provide physicians with free samples serve to advance healthcare (ie. provides a way to extend the post-marketing review of new name-brand medicines.)
“Instead of second-guessing motives, Harvard researchers would better serve patients by examining health outcomes. Clearly, free samples often lead to improved quality of life for millions of Americans, regardless of their income.
Is that free samples which improve quality of life? I thought that PhRMA's mantra was that drug research and miracle medicines improve the quality of life for millions of Americans.
“Free pharmaceutical samples can give physicians valuable first-hand experience with new treatment options. And free samples can help patients begin treatment sooner, find the right medicine, and offer an option for those who have difficulty affording their medicines.
Notice how the term 'free' has been used six times already?
“As the study authors note, when patients were seen by practitioners in their offices, uninsured patients ‘appear more likely to receive a free sample than do insured persons.’
“According to the study authors, this suggests that office-based
practitioners make a ‘sincere effort’ to use free samples to help needy patients.“Likewise, insured patients who lacked prescription drug coverage also were more likely to receive a free sample.
So PhRMA wants to remind the reader that 'free' (3 more times) samples are used to address the lack of prescription coverage for some patients and the neediness of others.
“Indeed, a recent Henry J. Kaiser Family Foundation survey found that 75 percent of physicians frequently or sometimes give free samples to assist patients with their out-of-pocket costs. An earlier survey examining key factors influencing physicians’ decisions to distribute free samples found the ‘patient’s financial situation’ was a considerable or strong influence 86 percent of the time.
'free' 2x more
"That said, the study released Jan. 2, which was conducted by Harvard Medical School and Cambridge Health Alliance researchers, was fatally flawed.
Here it comes... the official PhRMA mantra... the Partnership for Prescription Assistance is here to help. I've discussed PPArx before here, here, and here.
“The study, which relies on 2003 data, ignores significant outreach efforts in recent years, including the 2005 launch of the Partnership for Prescription Assistance (PPA), a program sponsored by America’s pharmaceutical research companies to help uninsured and underinsured patients.
“Our member companies recognize that, unfortunately, many uninsured and underinsured patients do not receive their medical care from office-based practitioners.
So does that mean that lack of medical care from office-based practitioners is to blame for the failings of pharmaceutical samples as an effective safety-net for uninsured and underinsured patients?
“And, as important as free pharmaceutical samples are in improving healthcare, they represent one – not the only – option for patients in need.
“As a consequence, over and above the billions of dollars in free samples that pharmaceutical research companies distribute to physicians, our companies have provided medicines worth more than $10 billion, in wholesale value, to nearly 5 million struggling Americans since PPA was launched.
“Additionally, we have hand-delivered information about accessing free or nearly free medicines to clinics and hospitals nationwide that serve low-income Americans. And we have connected more than 200,000 patients with clinics and healthcare providers in their communities.
'free' 4x more
“PPA is a clearinghouse for more than 475 public and private patient assistance programs. More than 2,500 brand-name and generic prescription medicines are available through the participating programs.
Please note that some of the participating programs are simply discount cards which may, or may not, give the holder as little as 0% off the retail price of their medication.
Patients who need help should call...where trained operators field calls in more than 150 languages...
Too bad the trained operator I spoke with last summer could not speak English.
So what's the big deal with that omission you ask?"The most troubling facet of the study is that it relies on data from 2003 to present a picture that could be markedly out-of-date, relative to what is occurring during physician visits today.
“In addition, the samples distributed during the study period tended to be pharmaceuticals to treat chronic conditions. Thus, it is predictable – not surprising – that there would be a strong linkage between patients’ age and receiving free pharmaceutical samples. Patient age strongly correlates to such medical conditions as arthritis, and uncontrolled cholesterol and blood pressure levels.
"The pharmaceutical samples that were distributed to those patients were new to the market and, at that time, were perceived by physicians to offer benefits to patients with uncontrolled disease.
"The distribution of free samples has become very controversial. Evidence shows that free samples may influence physicians' prescribing behavior and cause safety problems. For instance, we found that the most widely distributed sample in 2002 was Vioxx, with Celebrex being number 3. These drugs turned out to have lethal side effects. While many doctors still view samples as a safety net for their neediest patients, our study shows that samples are potentially dangerous, and do little for the needy."I guess PhRMA didn't really want to bring attention to the fact that some newly-approved, most-promising, blockbuster medications may have undiscovered lethal side-effects.
"We know that many doctors try to get free samples to needy patients when those patients come into the office. We found that such efforts do not counter society-wide factors that determine access to care and selectively direct free samples to the affluent. Our findings strongly suggest that free drug samples serve as a marketing tool, not as a safety net."
And if there is any doubt about that, just look to the controversy surrounding the proposed licensing of drug reps in Washington, D.C. and other jurisdictions in the country. It is widely accepted that drug reps are basically salespeople who go office-to-office to try to get physicians to prescribe more of their brand-name drug.
Please keep in mind that...
"Free drug samples are not the solution to the disproportionately low amount of health care resources going to the poor and uninsured; they are part of the problem," said Dr. Steffie Woolhandler, a physician at Cambridge Health Alliance, Associate Professor of Medicine at Harvard, and study co-author.(h/t WSJ Health Blog "Poor Get Short Shrift on Drug Samples.")
In 1976, at 43, Sontag discovered she had advanced cancer in her breast, lymphatic system and leg. She was told she had a one-in-four chance to live five years. After undergoing a radical mastectomy and chemotherapy, she was pronounced free of the disease. "My first reaction was terror and grief. But it's not altogether a bad experience to know you're going to die. The first thing is not to feel sorry for yourself."
She learned as much as possible about the disease and later wrote "Illness as Metaphor," an influential essay condemning the abuse of tuberculosis and cancer as metaphors that transfer responsibility for sickness to the victims, who are made to believe they have brought suffering on themselves. Illness, she insisted, is fact, not fate. Years later, she would extend the argument in the book-length essay "AIDS and Its Metaphors."¤¤¤ Life ¤¤¤
No one should have to put up with that kind of behavior, especially your closest and most intimate friend, the person you love most in life. Yet this situation is prevalent among couples affected by MS. I have made my life an open book with the goal of helping others avoid making the same relationship destroying mistakes that I have me.At his blog Defeating Illness, Chris primarily discusses issues surrounding his book.
Perhaps it is time to amble a bit more as we go through life, no matter what the weather. Goals are fine, achievements are dandy, but sometimes we can fail to appreciate the wonders of the process, the myriad sights and sounds, faces and places that are the fabric of our immersion in that which is our life. No matter what else it comes with, it comes only once—blades of grass one day, fuel for fire the next.Richard blogs at KEBENARAN - THE TRUTH.
[Still] ... I'll choose MS.
After following the developments of the small biotech company, Questcor Pharmaceuticals, Inc. which has sought FDA approval of H.P. Acthar Gel for the indication of Infantile Spasm, I definitely see the obscene importance placed on squeezing as much profit from a product as possible in the eyes of investors and executives.Gawande may be too polite to say this, but the answer seems to me clear. There is no profit to be made on a checklist. What do you sell? Any experienced intensive care specialist knows what should be on the list. All anyone needs is a few pieces of paper and a pencil. Pronovost has invented a process for delivering health care—not a new hi-tech procedure, not a new product. And like Jonas Salk, who invented the polio vaccine, he is willing to give his idea away for free.
If there were something to sell, Johnson & Johnson or Genentech would have turned Pronovost and his idea into a new medical breakthrough long ago. The story would be reported in U.S.A. Today, trumpeted on the Evening News, splashed on billboards across the nation. Hospitals would be spending millions on ads bragging that they had this new breakthrough product: “At Mount Hope, Where We Care About Your Safety…”
In our for-profit healthcare system, people become truly excited about an idea when someone sees way to make a fortune. So Merck’s new vaccine, Gardasil, that protects against 70 percent of the viruses that cause cervical cancer has gotten extended play in the press, on TV, and on Wall Street. Meanwhile, the Pap Smear—a test that detects virtually all cases of cervical cancer and has, in fact, made this type of cancer a “rare disease” in the U.S., gets little notice. No national campaign to make sure every woman gets annual Pap Smears. It’s not a high-profit procedure.
In the U.S. the idea that the point of healthcare is better health seems to have been lost in the rush to make money. As Harvard’s Dr. Arnold Relman wrote in the most recent issue
of JAMA, ours is “the only health system in the world” where “investors and business considerations play such an important role. In no other country are the organizations that provide medical care so driven by income and profit-generating considerations.”
Today (Sunday, Dec. 30) the New York Times published a shocking op-ed by Dr. Atul Gawande revealing that a U.S. government agency has stopped an enormously successful "checklist" program that was being used to reduce infections in intensive care units at Johns Hopkins and throughout the state of Michigan.
Below, an excerpt from today's op-ed:
" In Bethesda, Md., in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder. Consider this recent case.
"A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. . ."The results were stunning. . . . Over 18 months, the program saved more than 1,500 lives and nearly $200 million
"Yet this past month, the Office for Human Research Protections shut the program down. . .
"The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations," Gawande explains. "Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.
"The government’s decision was bizarre and dangerous," he adds. "But there was a certain blinkered logic to it, which went like this: A checklist is an alteration in medical care no less than an experimental drug is. Studying an experimental drug in people without federal monitoring and explicit written permission from each patient is unethical and illegal. Therefore it is no less unethical and illegal to do the same with a checklist. Indeed, a checklist may require even more stringent oversight, the administration ruled, because the data gathered in testing it could put not only the patients but also the doctors at risk — by exposing how poorly some of them follow basic infection-prevention procedures.
[However] "Excellent clinical care is no longer possible without doctors and nurses routinely using checklists and other organizational strategies and studying their results. There need to be as few barriers to such efforts as possible. Instead, the endeavor itself is treated as the danger.
"If the government’s ruling were applied more widely," Gawande notes, "whole swaths of critical work to ensure safe and effective care would either halt or shrink: efforts by the Centers for Disease Control and Prevention to examine responses to outbreaks of infectious disease . . .
"Scientific research regulations had previously exempted efforts to improve medical quality and public health — because they hadn’t been scientific. Now that the work is becoming more systematic (and effective), the authorities have stepped in. . . . The agency should allow this research to continue unencumbered. If it won’t, then Congress will have to," Gawande concludes.
