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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If The NIH's Budget Gets Slashed, Don't Expect #Pharma To Make Up The Difference

If The NIH's Budget Gets Slashed, Don't Expect #Pharma To Make Up The Difference | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The end of 2016 looked rosy for biomedical R&D funding. The 21st Century Cures Act had just been passed and it called for the addition of $6 billion to the NIH budget. The funds were added to support both Joe Biden’s “Cancer Moonshot” as well as other worthwhile research efforts. Given that the NIH budget had been at about $31 billion, this Act would provide long-sought, meaningful growth for the NIH’s efforts to understand the root causes of diseases that plague us all.

 

However, Congress can giveth, and Congress can taketh away. In President Trump’s proposed budget for the next fiscal year, he is calling for a $6 billion cut in NIH funding. Not surprisingly, the Trump proposal has raised alarms across the biomedical world. Dr. Laurie Glimcher, president of Dana-Farber Cancer Institute, put the draconian nature of this cut into perspective:

 

This more-than-decimation of the NIH budget has to be put into context. Over the last 10 years, NIH funding had already dropped by more than 13% in constant dollars–a source of great frustration to many physician-scientists, given the incredible potential we see before us in immunotherapy, in genome editing, in more efficient sequencing, in our ability to find insights within massive amounts of disparate data. Now to cut the NIH funding almost 20% beyond that… Since much of the NIH budget is devoted to ongoing grants, it is possible that the NIH may not be able to fund any new work at all in 2018.

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Rigid Inclusion/Exclusion Criteria Of Cancer Clinical Trials are Disgraceful & Unnecessary

Rigid Inclusion/Exclusion Criteria Of Cancer Clinical Trials are Disgraceful & Unnecessary | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Thousands of adult cancer patients with limited available treatment options are considered for clinical trials, but fewer than five percent are actually selected.

And that is a national disgrace. The 21st Century Cures Act, just signed into law by President Obama, supports the Vice President’s Cancer Moonshot, which identifies the low number  — less than five percent — of adult patients considered eligible for  cancer clinical research trials as one of the main  barriers to progress in the war against cancer. Compare this to the 60 percent of pediatric cancer patients who enroll in such studies. Why don’t adults appreciate the same imperative?
The fault lies not with our patients, but with those who design these studies. To maximize the likelihood of detecting clinically meaningful effects from the drugs being studied, trials seek fit, homogenous patient populations.

At first blush, this makes sense: investigators, and the Food and Drug Administration (FDA,) want to clearly define a drug’s safety and efficacy, and avoid erroneously attributing consequences of other medical conditions to the drug. It wouldn’t be fair, for example, in a patient with severe cardiac disease who experiences a heart attack while on a clinical trial, to say that this unfortunate event was unequivocally caused by a study drug.

As a consequence, many adults with cancer flunk the eligibility criteria that would allow them to join these trials, and the patients who are enrolled in these studies don’t truly reflect the U.S. population who will ultimately be treated by the approved drug.

Some in the field joke that a patient has to be an Olympic athlete to qualify for a study; but it’s no joke. Cancer clinical trial eligibility criteria are rigid — and recent research reveals that this is unnecessary.

 

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Pharma Guy's insight:

The cancer moonshot coupled with easing of scientific evidence required for FDA approval, should lead to a flood of new cancer drugs that will not be effective, but will require more creative marketing (for more on that, read “21st Century Cures for Pharmaceutical Marketing”; http://bit.ly/2hEta4X).

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How to Find Clinical Trials for Experimental Cancer Treatments & Learn If Your Qualify

How to Find Clinical Trials for Experimental Cancer Treatments & Learn If Your Qualify | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Who might benefit from a clinical trial for an experimental cancer treatment?

A common misperception is that such trials are strictly for patients who have reached the end of the road and have no more hope of being helped by standard treatments.

“But it’s not last-ditch,” said Dina G. Lansey, the assistant director for diversity and inclusion in clinical research at the Johns Hopkins Kimmel Cancer Center. New forms of immunotherapy are being tested in many types of cancer, and not just at late stages.


Doctors should head off the misunderstanding by routinely mentioning clinical trials early in a patient’s care as a possible future option, Ms. Lansey said. That way, patients may be less likely to believe it is being sprung on them because hope has run out.

 

[But what if you can't meet the inclusion criteria? For more on that, read  “Rigid Inclusion/Exclusion Criteria Of Cancer Clinical Trials are Disgraceful & Unnecessary”: http://sco.lt/6M3C9h]


“It’s less scary if you hear it early on,” she said.

But patients themselves are often the ones who seek out clinical trials, rather than waiting for doctors to refer them.

There are various ways to find clinical trials. Most major cancer centers post the trials in which they participate on their websites. But those listings will be limited to that hospital’s offerings. Other sites show more options.

The best known site is ClinicalTrials.gov, provided by the National Institutes of Health. It may seem daunting: It shows more than 50,000 studies of cancer, with some actively recruiting patients but others already finished or not yet open.

An easier approach may be a web page of the National Cancer Institute, which also offers a toll-free phone number, 888-624-1937, that connects to a referral coordinator.

Other groups also have coordinators, or “navigators,” who can search databases to help patients find trials that are right for them. The process usually starts with patients filling out a questionnaire with information about their diagnosis and treatment history.

 

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