Saturday, May 27, 2017

FDA Has Many Hurdles to Overcome in its Effort to Stem the Current Opioid Addiction Epidemic it Helped to Create

The FDA has made many efforts to deal with the current opioid addiction crisis. The latest is the establishment of a "Opioid Policy Steering Committee." Some of these efforts may have been compromised by the influence of patient advocacy groups sponsored by drug companies that produce and market opioids. Such groups have gotten a seat on FDA panels. So, one has to wonder who will be named to the new steering committee.

Listen to podcast below:

Read the transcript, which includes links to more information, below.

Wednesday, May 10, 2017

PhRMA Gets Religion & Purges Low Hanging Fruit

PhRMA, the pharmaceutical industry's primary lobbying group, announced changes to its membership structure that purged 22 companies of their membership or associate membership status.

Now, to be a member of PhRMA, you have to spend at least $200 million per year spent on research and research expenditures must equal to at least 10% of global sales (click on "Read more >>" below for details).

Back in January, John LaMattina (@John_LaMattina) former president of Pfizer Global R&ampD, writing in Forbes, suggested that big pharma companies secede from PhRMA.

"I cannot help but wonder if the interests of the big companies would be better served if they split from PhRMA," said LaMattina. “The formation of a new association would go a long way to create a separate identity for the truly big pharma companies. CEOs like Ken Frazier will readily be able to point out to the world who big pharma really is. It would also bring accountability to the industry and demonstrate its commitment to not just being successful–but also doing good.”

Perhaps to forestall such a secession or perhaps to appease president Trump -- who accused the drug industry of "getting away with murder" -- PhRMA ousted small pharma members who are shouldering most of the blame for drug price increases. Meanwhile, Pfizer -- the largest of the Big Pharma companies -- won't commit to keeping a lid on the prices IT charges for drugs (read "Ian Read – Bean Counter Pfizer CEO – Won’t Commit to Keep a Lid on Drug Price Increases").

Friday, May 05, 2017

The Benefits and Risks of Limiting Pharma Sales Rep Access to Physicians

Pharmaceutical sales representatives are faced with increasingly limited access to physicians as many academic medical centers and other healthcare centers adopt conflict of interest policies restricting detailing. This is another benefit versus risk challenge for physicians who need quick access to the latest information about novel drugs. Listen to podcast below:




Read the transcript, which includes charts, below.

Saturday, April 22, 2017

March for Science, Why I March

John (PharmaGuy) Mack
speaking at the March for Science in Doylestown, PA.
My name is John Mack and I live in Newtown.

On Twitter I am known as PharmaGuy – that’s P-H-A-R-M-A, plus “Guy!” I PUBLISH a newsletter for the pharmaceutical industry. And I have a graduate degree in Biochemistry.

Every day we benefit from medicines and vaccines created by scientists who work in pharmaceutical and government-funded research laboratories.

We need to discover new drugs faster and defend efforts that make those drugs cheaper and more accessible to everyone.

In doing so, however, we also need to defend the scientific methods the drug industry uses to prove that medicines WORK.

A big part of that process is the Food and Drug Administration, which ensures that drugs are proven safe and effective through rigorous clinical trials.

Today the Food and Drug Administration and other science-based agencies like the National Institutes of Health and the Environmental Protection Agency are under attack by the current administration,

WHICH intends to increase SPENDING on the military and decrease SPENDING on these and other science-based agencies that help improve our lives.

We should not have to sacrifice science for security.

DEFUNDING science impacts us on a local level whether the issue is the quality of our air and water, fracking, opioid drug abuse, or the heroin epidemic.

We need leaders who believe in data and scientific evidence to help solve these problems.

More scientists must get involved in politics today just as Benjamin Franklin did during the American Revolutionary War.

There is a war being fought today – a war against science.

We must defend science in THIS war.

Marching together is a good first step.

But we must follow up by electing pro-science leaders and ensure that they rely on evidence, not beliefs, when making decisions about our health, our environment, and our general well-being.

Thank you for listening and may Science be with you!

Wednesday, April 19, 2017

Speedy Drug Approval Versus Safe Drugs: Can We Have Both?

More user fees paid to the FDA by the drug industry and the push for less rigorous scientific proof in clinical trials may lead to faster drug approvals, but also more deaths due to side effects. Where’s the balance between speed and safety?

For the last few years I have been tracking data from the FDA regarding how much money it collects from the drug industry in prescription drug user fees to see those payments influence more than just how quickly the FDA is able to approve new drugs for marketing.

One stark correlation I noted with the rise in user fees was the sharp drop in the number of warning letters the FDA sends out. I guess this is actually a negative correlation. Interesting...


But the fees seem to be working. In 1992 it took the FDA 19 months on average to approve new drug applications. Today, when user fees account for about 70% of FDA's budget for the review of new drug applications, it takes the FDA only 10 months to approve a drug for marketing (see here).

But what about drug safety, which is the other responsibility of the FDA?

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