Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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558 Pharma Funded Post-Marketing Drug Studies and Not a Single Adverse Event Reported – Sounds Too Good to be True

Studies drug companies fund after medicines go on sale may be too small to detect rare side effects, a recent German study suggests.


Even if these so-called post-marketing studies do uncover previously undetected adverse events, physicians conducting the trials are often required to keep results confidential, limiting the potential for regulators or patients to learn about safety issues, according to the study in The BMJ.


When drugs are approved based on tests in only a few thousand patients, very little is known about long-term safety or the potential for rare side effects to occur when tens of thousands of people take the medicines, said lead study author Dr. Angela Spelsberg, medical director of the Comprehensive Cancer Center in Aachen, Germany.


"The fact that many physicians are obliged by contracts to handle adverse drug reactions as confidential business information rather than reporting them is very disturbing," Spelsberg added by email. "In light of the indispensable role of general practitioners and clinicians in detecting, diagnosing and publicly reporting adverse drug reactions, this means a very big threat to public safety."


For the study, Spelsberg and colleagues made freedom of information requests to three regulatory authorities responsible for registering post-marketing studies in Germany and obtained data on 558 studies.


Not one adverse event report could be identified from any of the 558 post-marketing studies.


Still, the study offers fresh insight into several potential shortcomings of post-marketing drug studies, said Dr. Barbara Mintzes of the University of Sydney in Australia.


"When a drug first comes to market it has been tested on average in 2,000 to 3,000 people, too few people to uncover most rare serious harmful drug effects," Mintzes, who wasn't involved in the study, said by email. "Often, patients at greatest risk of harm like the frail elderly or people with several serious health conditions are excluded from the trials, so post-marketing safety studies are very important."


[What’s even worse is the fact it takes many years to complete these studies (see here) while the drug is on the market.]

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FDA Defends Expedited Oncology Drug Approvals, Neglects GAO Criticism

FDA Defends Expedited Oncology Drug Approvals, Neglects GAO Criticism | Pharmaguy's Insights Into Drug Industry News |

Richard Pazdur, M.D., Director of the Office of Hematology and Oncology Products, highlights some of his office’s 2015 approvals and discusses a few of the expedited review programs that are used by the office.

In 2015, the Office of Hematology and Oncology Products (OHOP) approved 16 new molecular entities (NMEs). The most notable were drug approvals in disease areas such as non-small-cell lung cancer, colorectal cancer, breast cancer, melanoma, renal cancer, and diseases that are particularly difficult to treat like pancreatic cancer.

FDA reviews new drug applications according to timeframes established by the Prescription Drug User Fee Act (PDUFA). There are also programs in place to expedite the drug development and review timeline, and many of the innovative therapies that were approved by OHOP this past year received an expedited designation. Generally, these designations are given to therapies that we consider to be better than what is currently on the market or that fulfill an unmet medical need. The accelerated approval, priority review, and breakthrough therapy programs are frequently used with new oncology drugs, and often a single drug receives multiple designations.

Pharma Guy's insight:

Dr.. Pazdur notes that "Following an accelerated approval, companies conduct additional confirmatory clinical trials with the drug to further examine its clinical benefit."

He does not mention the GAO report that found "FDA’s data on postmarket safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult.":  

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Pharma Marketing Blog: Tufts New Estimate of Costs to Bring a Drug to Market & Beyond

Pharma Marketing Blog: Tufts New Estimate of Costs to Bring a Drug to Market & Beyond | Pharmaguy's Insights Into Drug Industry News |

The pharmaceutical industry is currently struggling to defend the high cost of drugs. It is using advertising and lobbying to reach lawmakers and payers (read, for example, "#Pharma Ramps Up Ads & Lobbying to Fend Off Rx Pricing Regulation").

PhRMA's multi-million dollar "From Hope to Cures" campaign, for example, pulls the heart strings by featuring a 5-year-old boy with Type 1 diabetes. This is part of PhRMA's pledge to spend several million dollars this year, and 10% more than in 2015, on digital, radio and print ads that emphasize the industry’s role in developing new drugs and advancing medical science. It also plans to spend more money lobbying and donated to political campaigns.

In these campaigns, the strategy is less focused on defending drug costs to pay for the cost of developing new drugs and more focused on the benefit of new drugs in fighting intransigent diseases such as diabetes, rare cancers, and Alzheimer's Disease.

Nevertheless, many pharma CEOs still speak of "return on capital" to defend high drug prices.

So capital expenditures (R&D costs) are still a big deal for pharma executives. I have been reporting on various estimates of the costs to bring new drugs to market for several years now. Most of these estimates come from the Tufts Center for the Study of Drug Development.

Tufts has a new estimate of these costs that includes a new cost item.

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