DRUG BIZ | Danger–FDA Deregulation Ahead (by D. Posnett)

(Ill. by Patrick George)

The FDA's ability to ensure safe drugs has been
curtailed in the name of reducing costs and getting
more drugs to market. Caveat emptor! 

The following Guest Post was sent to me as a draft letter to the editor by an MD friend, David Posnett. He describes a worrisome price that the GOP-controlled Congress has exacted to get funding restored to the NIH for medical research. I asked Dr. Posnett if I could post this today and he kindly gave his permission.

The 21st Century Cures Act passed Congress Dec. 7 and was signed into law Dec. 13 by President Obama. This is a huge bill with something in it for everyone, and lots to criticize. As a retired researcher who spent nearly 40 years of my life writing research grants mostly to the National Institutes of Health (NIH), I applaud the long-overdue increase in funding of the NIH. In fact funding had steadily decreased in an alarming fashion since sequestration in 2013—inflation-adjusted funding for the NIH fell 22 percent in 2013-15.

Now there is a chance to catch up on these losses, in part because of The 21st Century Cures Act. It is well documented that reduced federal funding leads to fewer grants, fewer new discoveries and a loss of talented scientists. I have seen this first hand. Research scientists and patient advocate groups welcome the prospect of more funding.

However, there is an ugly underbelly to the 21st Century Cures Act. Perhaps not so well appreciated is further erosion of the power of the FDA in keeping us safe from drugs that can be harmful, or that are just ineffectual.

Remember the Thalidomide Babies?

It took lots of courage for a young FDA scientist in 1960 to stand up to the powerful drug industry trying to promote a poorly researched drug named Thalidomide.  Frances Oldham Kelsey was the FDA scientist who kept Thalidomide off the U.S. market and blocked approval for 19 months, thus saving thousands of babies from being born with severe deformities in the US. In other countries, without a strong FDA, sales and marketing for pregnancy-associated nausea remained unchecked and tens of thousands of severely deformed babies were born resulting in untold suffering across the globe.

In the name of accelerating drug development the FDA’s authority and the lengthy process of FDA approval have been steadily been eroded over the last few decades and the 21st Century Cures Act could be a fatal blow, specially with a new government bent on deregulating. Lobbyists from the pharmaceutical and medical device industries, and allied patient advocacy organizations, are touting predicted miracle breakthroughs based on the law’s aim to weaken regulations and promote rapid drug development. 

Most egregious is the use of anecdotal clinical experience as evidence that drugs are safe and effective; allowing antibiotics on the market based on pre-clinical evidence, that is, laboratory or animal studies, with little testing in humans; weakening the already limited evidence needed to approve medical devices (for example a stent for a coronary artery), even allowing companies to farm out the certification of safety of modified devices to third parties, circumventing the FDA altogether.  Similar concerns have been voiced in several leading medical and science publications (New England Journal of Medicine, JAMA, Science and Nature).

"Giveaway" to the Drug Biz 

As stated by Michael Carome (Director, Health Research Group, at Public Citizen) in the LA Times, “If universal praise for a measure makes your B.S. detectors twitch, you’re on the right track. The 21st Century Cures Act is a huge deregulatory giveaway to the pharmaceutical and medical device industry, papered over by new funding for those research initiatives.” 

Nothing in this act addresses the main problem the public sees with the drug industry: unaffordable prices. Elizabeth Warren says: “When American voters say Congress is owned by big companies, this bill is exactly what they are talking about.”   

Consider Merck’s Vioxx, a painkiller and arthritis drug the FDA approved in 1999. Vioxx was pulled off the market in 2004 after it was shown to raise the risk of heart attacks. By then, according to research published in the Lancet (a premier British medical journal), 88,000 Americans had heart attacks from taking Vioxx, 38,000 of them fatal.

Personally, I will be a lot more reluctant to take a new medication that has not stood the test of time!  This position is what I would recommend to my patients.

David Posnett MD

Springs, East Hampton, N.Y.

CANDIED CIGARS | To Help Along Your Addiction

Worse than candy cigarettes? Sweet-flavored cigars–peach, honey, grape...

Two of my closest relatives smoked and died young. The other lived ten years longer:

• My Dad did not smoke cigarettes, but he did smoke cigars and a pipe. He suffered from dizziness in his last decade of life, had a stroke and died in his 80s. 
• His brother died of emphysema that he attributed entirely to the cigarette smoking that he started in the Navy in WWII. He quit at 60 years of age but it was too late. He suffered decades of wheezing and also died in his 80s. 
• My nonsmoking mother died at 98. 

A sample of just three people in one family - but the family fits the statistics.

So when the FDA prohibited candy cigarettes, effective in 2010, I applauded. Let's stop allowing kids to be addicted in stages with cig sweets and then sweet cigs. But the vendors apparently just had to remove the red tip on the candy cigarettes and rename them "candy sticks".

I went to a site on Amazon that still advertised candy cigarettes in 2011 and gave the product a one-star review, calling it a diabolical product because it encourages kids to start smoking. As of today there were 26 posts, mostly complaining that I was a self-appointed candy-cig vigilante. Only three of 101 readers found my review helpful - thanks, you three. But the product did get 17 other one-star reviews for poor quality.

Now, today, we find from Sabrina Tavernise of the New York Times that marketers determined to addict as many kids as possible to tobacco are finding another avenue for creating new (short-) lifetime customers - candy-flavored cigars. So much for all the protests under my Amazon review that the candy cigarettes were just for "nostalgia" or even "an alternative to smoking"! Yeah, sure.

Why should anyone care who gets addicted to cigarettes or cigars? Isn't it good for the economy? Well, doctors and researchers tell me that smoking is about the worst thing one can do to destroy one's health. It reduces the length of one's working life, and the health-care costs of lung cancer etc. are huge. The greatest threat to the balancing of the Federal Budget, the greatest cause of the financial difficulties of many U.S. manufacturing companies, is the cost of health care.

Cigarette addiction has multiple victims – the people who smoke and destroy their health, the families that must cope with the problems of having a sick person in the house, and the corporations and taxpayers who have to pay for the long years of health care before nature sends her Final Signal of her disapproval of the smoking habit.

For many who are addicted it may be too much to give up cigarettes or cigars. But to anyone who complains about the candy-cig police and is happy to see another generation hooked on tobacco, the only words that come to my mind are "invincible ignorance".