Pharma & Data Transparency

"self portrait" by shawnchin  (2005) CC BY-SA 2.0

self portrait” by shawnchin (2005) CC BY-SA 2.0

I absolutely adore those instances when my job and my degree dovetail, so reading about the pharmaceutical industry’s latest proposal for more transparent data was quite interesting. The interplay between data transparency to validate the effectiveness of clinical trials and protecting the privacy of the patients involved in those trials is certainly proving to be a delicate balance to strike.

The New York Times reports:

Representatives of the world’s biggest pharmaceutical companies pledged … to release detailed data about their drugs to outside researchers, a move that was applauded by some but also seen as an effort to head off more extensive disclosure requirements that are under review in Europe.

Yet, just a few months ago the Pharmaceutical Research and Manufacturers of America (PhRMA) had released a statement in response to Dr. Ben Goldacre’s Bad Pharma, which criticized the recommendations for transparent clinical trial data as “encourag[ing] second-guessing of the regulatory approval process, which would be disastrous for patients,” and could potentially “jeopardize patient privacy and could serve as a deterrent to individuals considering participation in trials.”

The New York Times goes on to point out that “proponents say doctors and patients need independent information — not just that provided by manufacturers — about the risks and benefits of drugs.” Meanwhile, there is already skepticism brewing in the wings. These developments should prove quite fascinating to follow in the months leading up to the proposed January 2014 adoption date.

Public health and drug compounding

From the New York Times, a story of how pharmaceutical compounders have been able to secure less oversight than most pharmaceutical companies.

Despite two decades of dire health warnings and threats of federal intervention, the specialty drugmakers at the center of the nation’s deadly meningitisoutbreak have repeatedly staved off tougher federal oversight with the help of powerful allies in Congress.

Over the years, industry friends like Tom DeLay, the former House Republican leader from Texas, have come to its defense. Even Senator Edward M. Kennedy, regarded as the strongest health care advocate in Congress in recent times, dropped efforts to impose new safeguards.

But the pharmacists known as compounders are now facing their biggest regulatory threat as they confront questions on Wednesday and Thursday at Congressional hearings on the deadly outbreak. The question is whether Congress will move to oversee the niche industry more aggressively.

“A lot of the blame for the meningitis situation lies at Congress’s door,” said Larry D. Sasich, a research pharmacist who has written about compounders’ safety record. For specially mixed drugs that fall into a gray area of federal law, he said, “the protections for your cat or dog are stronger than for your wife and children.”

Read the complete story here.

Sanofi halves price of cancer drug Zaltrap after Sloan-Kettering rejection

From the New York Times:

In an unusual move, a big drug company said on Thursday that it would effectively cut in half the price of a new cancer drug after a leading cancer center said it would not use the drug because it was too expensive.

The move — announced by Sanofi for the colon cancer drug Zaltrap — could be a sign of resistance to the unfettered increase in the prices of cancer drugs, some of which cost more than $100,000 a year and increase survival by a few months at best.

Zaltrap came to market in August at a price of about $11,000 a month. Soon after, Memorial Sloan-Kettering Cancer Center in New York decided not to use the drug, saying it was twice as expensive but no more effective than a similar medicine, Avastin from Genentech. Both drugs improved median survival by 1.4 months, doctors there said.

Three doctors at Sloan-Kettering publicized the cancer center’s decision last month in an Op-Ed article in The New York Times.

Read the complete story here.

India weighs providing free drugs at state-run hospitals

From the New York Times:

In what would be a landmark increase in the Indian government’s spending on public health, New Delhi is completing a proposal to provide hundreds of essential drugs free to patients in government-run hospitals and clinics at a cost of nearly $5 billion over five years, officials said Thursday.

The proposal, which could receive government approval next month, would try to fill a gaping hole in the provision of health care at state-owned hospitals, many of which require patients to buy their own drugs, including substances as basic as intravenous fluids. Specialists say it could also be the first step toward a more comprehensive universal health care system in India, which, with 1.2 billion people, is the world’s most populous country after China.

Drugs account for more than 70 percent of out-of-pocket medical costs for Indians. Government hospitals and clinics provide free or low-cost care, but most of them struggle to keep up with demand, and the quality of care can be poor.

Read the complete article here.

Medication Safety and Medical Resident Supervision

The February issue of AHRQ Web M&M features a Spotlight Case on e-prescribing when a error was noted and cancelled in teh patient record, but not in the pharmacy.

Commentary is provided by Elisa Ashton, PharmD., an assistant clinical professor at the University of California, San Francisco. Perspectives on Safety features an interview with Lawrence Smith, M.D., the founding Dean of Hofstra North Shore-Long Island Jewish School of Medicine, and an expert on the relations between medical training and patient safety. C. Jessica Dine, M.D., M.A., and Jennifer Myers, M.D., assistant professor of medicine and associate professor of medicine, respectively, at the University of Pennsylvania, discuss the ongoing tension between balancing supervision of physician trainees and attaining clinical autonomy.

Physicians and nurses can receive free CME, CEU, or training certification by taking the Spotlight Quiz.

Combination of oral drugs suppresses common type of hepatitis C, according to University of Michigan-led research

Led by University of Michigan researcher Dr. Anna Lok, this study indicates that interferon free treatment for hepatitis C may be possible in the near future.

“In this pilot study, patients with hepatitis C genotype 1 infection, who had not responded to previous treatment with PEG-interferon alfa and ribavirin, were given a combination of two investigational direct-acting antiviral agents (daclatasvir and asunaprevir) alone, or were given these two antiviral agents along with PEG-interferon alfa-2a and ribavirin.”

“Although only four of 11 patients given the two direct-acting antiviral agents only achieved sustained virologic response, this is the first study to show that sustained virologic response can be achieved without the use of interferon or ribavirin.”

Dr. Lok’s research is funded in part by the Ann Arbor-based Greenview Foundation Hepatitis C Research Fund.

For the full article please go to:

Epocrates–The App is Free, but Come with Focused Ads

Epocrates, provider of a very popular free phone app that lets clinicians look up information on drug dosing, interactions and insurance coverage while seeing a patient, has a problem:  advertising.  According to an article in the New York Times, “the apps can select messages based on each doctor’s search and prescription histories, and the company has ambitious plans for expanded smartphone offerings. One possibility is a virtual sales rep that would help drug makers get their wares in front of physicians who decline to see human sales representatives.”

“Pfizer, the world’s largest drug maker, has certainly found the marketing channel to be an effective way to reach doctors. “The beauty of the work we do with Epocrates is that we literally put ourselves in the palm of their hand,” said Dr. Freda Lewis Hall, chief medical officer at Pfizer.”

LactMed Adds Complementary and Alternative Medicine Products

LactMed, the National Library of Medicine’s database of drugs and other chemicals to which breastfeeding mothers may be exposed, has added complementary and alternative medicine (CAM) products.

LactMed focuses on potential side effects in mothers and infants and on other problems associated with the products. The CAM records, currently 19 with 100 expected, feature a new field for the products’ scientific genus and species names.

 A complete list of CAM records in the database can be found by searching for “complementary therapies” in the main LactMed search box.

CAM Listing