Life Science Compliance Update

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27 posts from August 2011

August 31, 2011

ProPublica Dollars for Docs Campaign of Shame II: Coming to Your Local Media Outlet September 8th

Wanted poster doctor 
In the old west posters were put up around town looking for criminals and wanted men.  Today, industry critics are assembling wanted posters and list of who they consider their enemies, but this time it is hard working doctors as opposed to criminals.  They are seeking to shut down the relationships between physicians and industry scientists working on cures with their Dollars for Docs “campaign of shame.”  

Almost one year ago, the infamous and so-called “investigative journalist” shop known as ProPublica, published its Dollars for Docs database.  The database combined seven pharmaceutical companies’ payment data and created a searchable site to see how much a particular doctor was paid. 

Of course, the website and media stories that followed failed to portray such payments in an objective manner and offered minimal, if any context of such payments, publishing numerous articles about only the potential negative consequences of physician-industry payments and collaboration.

Consequently, ProPublica announced this week that it is preparing a major update to its Dollars for Docs database on September 8, 2011.

In doing so, ProPublica privately invited “news organizations to participate in a roll-out of stories based on the new data.”  In other words, ProPublica is getting ready to attack more hardworking physicians who educate their peers, conduct clinical research, and consult with industry to ensure that Americans have the most advanced treatments and medicines. 

In fact, ProPublica is “offering the data in advance to all interested news organizations that agree to withhold publication of their stories prior to the launch of their update.”

ProPublica said it “will make the data available on Aug. 22, under an embargo that lifts at 9 p.m. on Sept. 7.”  In addition, ProPublica stated that they can provide media sources “with payment data for the state or states you cover, as well as a guide to using the data,” and reporters Charles Ornstein and Tracy Weber will also be available to offer advice and tips.  Essentially, ProPublica will be feeding their stories and biased viewpoints to local media sources.

In the past, local media sources simply would do a “search” on the ProPublica database for doctors in their area, and then publish a one-sided article critical of industry.  Such articles were hardly if ever “objective,” and almost never included an opposing viewpoint showing the value of physician-industry collaboration.

According to their email, ProPublica will publish an updated version of their searchable database of payments that will now include data from 12 drug companies (about 40 percent of the U.S. market). The new information includes a full year of data from eight of those companies, allowing the first head-to-head comparisons of the fees paid by those companies. ProPublica “guaranteed” local media sources that its articles and update will “have a local angle of interest to your audience.”

Clearly all ProPublica cares about is getting media sources to expand the reach of their shame campaign, not truthful and objective journalism.

In addition, ProPublica claimed in their email that, “conflicts of interest in medicine have been a major issue for the past several years,” and noted how the Physician Payment Sunshine Act was enacted as part of the Affordable Care Act to address these so called “conflicts.”  The Sunshine Act requires pharmaceutical and medical device companies to post all payments to physicians of $10 or more, with certain exceptions.  They noted that while, “some companies have started doing so before then, either voluntarily or as the result of legal settlements, the payments listed on the companies’ individual sites are not easy to search and analyze.” A reason they use to justify the creation of their database, which they claim is “easy to use.”

The real question is, of what value is “analyzing” such payments?  Will analyzing such payments lead to better patient outcomes? Will drugs, devices or treatments get to patients sooner and through FDA approval faster?  Will clinical trials be conducted more safely and efficiently because payment data is now available?  Or will the publishing of such payments have the opposite effect?  Will posting physicians name chill the willingness of researchers to do research, educate their peers, and consult with companies? Will the added costs of transparency have any benefits to outweigh the administrative and resource burdens?

ProPublica asserts that its database has now “become even more useful for consumers.” But in what way? Is there any research to show that over the past year, since ProPublica published its first data, that patients are safer and healthier? No. ProPublica has not offered one shred of evidence to show that their database has done anything positive to make Americans safer or healthier.

Instead, ProPublica just wants to ostracize physicians who collaborate with industry and make lifesaving treatments and scientific discoveries.  They want people to “see which doctors in your communities have stopped speaking on behalf of drug companies and which have recently joined up.” And for what? Will this mean that patients will stop seeing their doctors, or will they ask their physicians why they take the time out of their busy schedules and family lives to educate other physicians, conduct clinical trials, and do research and consulting?

Ultimately, ProPublica will continue to abuse and slant the portrayal of physician-industry collaboration, throwing sand into the gears of medical and scientific progress, harming patients and leading to Americans and patients suffering.  In the coming weeks, we will be getting comments from local physicians who work and collaborate with industry to offer the counterpoint to ProPublica to highlight the tremendous value physician-industry collaboration brings to patients and America.

ACRE Releases Statement on Enhancing FDA Advisory Committee Recruitment

FDA Advisory Committee 
The Association of Clinical Researchers and Educators (ACRE) today announced its support for reforms to the Food and Drug Administration’s (FDA) conflict of interest standards.  ACRE strongly recommends that FDA adopt new policies that ensure experts with the highest scientific and clinical qualifications are actively recruited to serve as advisory committee members.

The FDA regulates more than 150,000 marketed drugs and medical devices, with nearly 3,000 investigational new drugs being developed at any given time.  These advances offer hope for patients and the opportunity to improve public health, which must be balanced against the potential risks.

Although FDA employees have extensive scientific and medical training and experience, they cannot alone encompass the full range of expertise necessary to evaluate the increasingly complex minutiae associated with medical innovation.  The agency therefore looks to outside experts to serve on technical and scientific advisory committees that evaluate the safety and efficacy of experimental products. Advisory committees provide crucial independent advice to assist with regulatory decision-making processes and support sound decision-making by the FDA.

In 2007, new conflict of interest standards were adopted that set an arbitrary financial threshold for committee participation.  Experts with personal or family financial interests above $50,000 are excluded from serving as committee members, and even if conflicts are resolved, they must wait at least one year before being permitted to serve.  Those with interests below the threshold are allowed to serve, but are stripped of their voting rights.

Since adoption of these new policies, committee vacancy rates have steadily increased.  The most recently released data for overall FDA committee membership from the third quarter of 2010 show vacancy rates ranging from 25% to 27%.  The Center for Biologics Evaluation and Research (CBER) vacancy rates are markedly worse, reaching 32% for the last three months of 2010.

“These rising vacancies clearly demonstrate the unintended consequences of overly restrictive conflict of interest policies,” stated Michael Weber, MD, a Director of ACRE, “Both government and industry rightfully seek out accomplished leaders in many fields for their expertise.  Excluding a portion of these leaders because they have collaborated with industry to promote advancements in science and health is hindering the FDA’s ability to meet its responsibilities to patients.  Product reviews are unnecessarily delayed along with patients’ access to new therapies and medical devices.”

Data obtained by both critics and supporters of industry collaboration consistently reveal that industry consultants are often the most qualified and prominent physicians and productive researchers.  Moreover, detailed analysis of FDA panels’ recommendations reveals no effect of industry relationships on panel members’ voting behavior.

“Advisory committee members should be chosen based on their direct experience with, and expert knowledge of, the specific technology under review,” stated Weber.  “ACRE supports a transparent evaluation process under which remuneration from for-profit and non-profit entities is examined and made available to the public. Relationships that indicate direct financial interests with an entity whose product is the subject matter of a particular Advisory Board meeting would reasonably lead to recusal of a potential advisor..  Other interests, including so-called perceived conflicts, should not be used as exclusion criteria.”

“We urge the FDA to further scrutinize the impact its current conflict of interest policy is having on product reviews and approvals and make the appropriate adjustments.”

About ACRE

The Association of Clinical Researchers and Educators (ACRE) is a non-profit professional organization of medical professionals dedicated to the advancement of patient care through productive collaboration with industry and its counterparts. ACRE seeks to define and promote balanced policies at academic medical centers and within government that will enhance rather than interfere with our highly valued collaboration. In addition, ACRE will identify and train next generation of researchers and educators.

Drug Shortages Potential Causes Stricter FDA, Price Controls and Policies Against Newer Medications

Drug Shortages 2 
Over the past two years shortages have developed for over 180 drugs, including cancer treatments. According to a recent article written by Robert Goldberg, vice president of the Center for Medicine in the Public Interest, “the shortfall is the result of stricter Food and Drug Administration (FDA) regulation, government price controls on already discounted but complex drugs, and policies that discourage the use of new medications.”

Goldberg explained that, “companies, facing lower prices, tighter regulation and increasing government control over what drugs will be used and when, are exiting the U.S. market and investing in product development in China and India where, sadly, it is easier and cheaper to produce next-generation medicines.”

He added that, “stockpiling will only add to people's suffering by replacing market reforms with government micromanagement. Government planners require months, if not years, to produce regulations, bids and supply estimates that are usually overgenerous to compensate for paltry prices. Government bungling was behind the failure of the smallpox and H1N1 vaccine program and responsible for billions of dollars in flu vaccines and antibiotics being dumped. The same forces pushing stockpiling also believe commercializing medical discoveries is evil.

Consequently, Goldberg asserted that, “the drug shortage is a product of a more troubling trend.” At a time when medical research could yield breakthroughs in the treatment of obesity, Alzheimer's, diabetes, and stroke, among others, he maintained that, “innovation has all but dried up.”

Most of the medicines being used today were developed 30 years ago. Most of them have generic competition. They have contributed greatly to increased wellbeing but, as the return on generic drugs fall, price controls and regulation have created shortages. As a result, Goldberg asserted that, “Obamacare is making the commercialization of newer drugs and devices more difficult.”

Though new and faster methods to determine a technology's safety and effectiveness exist, Goldberg argued that, “Obama's FDA still demands evidence collected with science and statistical methods developed in the 19th century.” To emphasize this point, Goldberg noted that while “in the last two years, new medicines for AIDS, cancer, lupus and hepatitis have been developed, these products should have been available sooner if not for FDA nitpicking.”

Although the drugs are finally approved, patients are finding it next to impossible to access several new drugs and genetic tests that would transform the quality of life and extend survival for such illnesses as lupus, prostate cancer, and organ transplantation.

For example, Goldberg pointed to Provenge, the first cancer vaccine, which stalled at the FDA for years. Once approved, it faced 18 months of additional delay while the Obama administration figured out whether to pay for it. Goldberg asserted that, “the gauntlet cancer patients face with Provenge is being extended to everyone waiting for a medical breakthrough under Obamacare.”

Additionally, Goldberg pointed out that, “before a medical innovation can be used or paid for, the government will now demand additional research demonstrating that a new product will be more effective and cheaper than existing technologies. Since most new products come from small start-ups with limited cash, such a requirement means life-saving innovations will not be available at all.”

Moreover, he noted that, “before the cancer drug shortage there was the decision that women under 50 should not get mammograms. Both Provenge and Benlysta, new treatments for prostate cancer and lupus respectively, are hard to come by because of uncertainty about reimbursement by health plans and government.”

Ultimately, Goldberg maintained that, “the death and suffering flowing from such delays are the result of policies promoted by those who want to use the FDA and increased government control over medicine to slash access to new technologies.” He added that, “the shortage of old drugs is simply one side effect of this malevolent strategy.”

In the end, Goldberg asserted that, “no one in America should go without medicine because they can't afford it and this shouldn't be a nation where people are denied treatments because their government makes medicine impossible to produce or obtain.”

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