Pharma

An investigation by Pro Publica’s Charles Ornstein, Tracy Weber and Jennifer LaFleur found that at least 17 of the top 20 prescribers of Bystolic, a blood pressure medicine, in Medicare’s prescription drug program in 2010 have been paid by the drug maker Forest Laboratories to deliver promotional talks. In 2012, they together received $283,450 for speeches and more than $20,000 in meals. Pay-to-prescribe is illegal, but these doctors say they haven’t been influenced by the money they get for promoting drugs they also prescribe to large numbers of their patients. Read More.

A new study in Journal of Health, Politics, Policy and Law shows how five leading drug companies violated industry-developed standards for ethical advertising in the United States. The authors demonstrate a consistent failure by companies that market erectile dysfunction drugs to comply with the industry’s guiding principles for ethical DTCA despite pledges of compliance by company leaders.  They recommend policy responses to prevent deceptive practices, protect children from adult content, and promote genuine health care education.

Pharmed Out, a Georgetown University Medical Center project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices,  has created a new set of drug ad resources that can be used to teach about pharmaceutical industry drug advertising tactics. 

A new study published online by the Journal of Internal General Medicine compared information provided by pharmaceutical sales representatives to primary care physicians in cities in Canada, France and the United States. “Minimally adequate safety information” did not differ in the US and Canadian sites, despite regulatory differences. In France, consistent with stricter standards, more harm information was provided. However, the authors found that in all sites, physicians were rarely informed about serious adverse events, raising questions about whether current approaches to regulation of sales representatives adequately protect patient health.

People in developing countries worldwide will continue to have access to low-cost copycat versions of drugs for diseases like H.I.V. and cancer, at least for a while, reports the New York Times.  While advocates for the pharmaceutical industry argue that liberal rules on patents spur innovation, a growing number of countries are questioning why they should pay high prices for new drugs. Production of the generic drugs in India, the world’s biggest provider of cheap medicines, was ensured on Monday in a ruling by the Indian Supreme Court. Specifically, the decision allows Indian makers of generic drugs to continue making copycat versions of the drug Gleevec, used to treat forms of leukemia, which is made by Novartis. The ruling will also help India maintain its role as the world’s leading provider of inexpensive medicines. Gleevec, for example, can cost as much as $70,000 a year, while Indian generic versions cost about $2,500 a year.

Spending on prescription drugs nationwide has been slowing for years, reports the New York Times, because of the increasingly widespread use of low-cost generics. But in 2012, something unheard-of happened: money spent on prescription drugs actually dropped. But some are warning that the ever-expanding use of generics has masked a growing problem for the government, insurers and others who pay the bill for prescription drugs: the rising cost of complex specialty medicines that treat cancer, rheumatoid arthritis and other diseases.

The Wall Street Journal reports that the Supreme Court on Wednesday cleared the way for a securities-fraud lawsuit alleging Amgen Inc played down safety concerns about two drugs used to treat anemia. The court’s 6-3 decision, written by Justice Ruth Bader Ginsburg, affirmed a lower-court ruling that had certified the lawsuit to proceed as a class action. The suit, brought by Connecticut pension funds on behalf of purchasers of Amgen stock, alleged the Thousand Oaks, Calif., company repeatedly reassured investors about the safety of anemia drugs Aranesp and Epogen even as clinical trial data raised concerns that the drugs could harm cancer patients. Amgen’s statements led to inflated share prices, the suit alleged.

Executives at Johnson & Johnson, the American multinational medical devices and pharmaceutical corporation, knew years before they recalled [the] troubled artificial hip in 2010 that it had a critical design flaw, The New York Times writes,  but the company concealed that information from physicians and patients, according to internal documents disclosed on Friday during a trial related to the device’s failure.

India’s Intellectual Property Appellate Board  is hearing Bayer’s appeal to the government’s compulsory license for patents on the drug Sorafenib (sold under the brand name Nexavar by Bayer). Used to treat kidney and liver cancer,   the drug costs 2,800,000 rupees (USD 5,214) per patient per month and the generic costs 8,880 rupees (USD 165) per patient per month.  The compulsory license was issued under Section 84 of the Patents Act, on the grounds that the invention was “not available to the public at a reasonably affordable price,” and therefore not reasonably worked in India.   Read more