Category Archives: drug manufacturers

Waiting for a Vaccine

 

While the world, in the midst of a deadly pandemic, turns to science and medicine to find a vaccine that would make us all safe, I can’t help remembering a long-ago time in my life when the world faced another deadly disease.

And I vividly remember how a vaccine, the result of years of dedicated research, led to the triumphant defeat of that disease.

Covid-19 poses a special threat.  The U.S. has just surpassed one million cases, according to The Washington Post.  It’s a new and unknown virus that has baffled medical researchers, and those of us who wake up every day feeling OK are left wondering whether we’re asymptomatic carriers of the virus or just damned lucky.  So far.

Testing of the entire population is essential, as is the development of effective therapies for treating those who are diagnosed as positive.  But our ultimate salvation will come with the development of a vaccine.

Overwhelming everything else right now is an oppressive feeling of fear.  Fear that the slightest contact with the virus can cause a horrible assault on one’s body, possibly leading to a gruesome hospitalization and, finally, death.

I recognize that feeling of fear.  Anyone growing up in America in the late 1940s and the early 1950s will recognize it.

Those of us who were conscious at that time remember the scourge of polio.  Some may have memories of that time that are as vivid as mine.  Others may have suppressed the ugly memories associated with the fear of polio.  And although the fear caused by Covid-19 today is infinitely worse, the fear of polio was in many ways the same.

People were aware of the disease called polio—the common name for poliomyelitis (originally and mistakenly called infantile paralysis; it didn’t affect only the young) — for a long time.  It was noted as early as the 19th century, and in 1908 two scientists identified a virus as its cause.

Before polio vaccines were available,  outbreaks in the U.S. caused more than 15,000 cases of paralysis every year.  In the late 1940s, these outbreaks increased in frequency and size, resulting in an average of 35,000 victims of paralysis each year.  Parents feared letting their children go outside, especially in the summer, when the virus seemed to peak, and some public health official imposed quarantines.

Polio appeared in several different forms.  About 95% of the cases were asymptomatic.  Others were mild, causing ordinary virus-like symptoms, and most people recovered quickly.  But some victims contracted a more serious form of the disease.  They suffered temporary or permanent paralysis and even death.  Many survivors were disabled for life, and they became a visible reminder of the enormous toll polio took on children’s lives.

The polio virus is highly infectious, spreading through contact between people, generally entering the body through the mouth.  A cure for it has never been found, so the ultimate goal has always been prevention via a vaccine.  Thanks to the vaccine first developed in the 1950s by Jonas Salk, polio was eventually eliminated from the Western Hemisphere in 1994.  It continues to circulate in a few countries elsewhere in the world, where vaccination programs aim to eliminate these last pockets because there is always a risk that it can spread within non-vaccinated populations.

[When HIV-AIDS first appeared, it created the same sort of fear.  It was a new disease with an unknown cause, and this led to widespread fear.  There is still no vaccine, although research efforts continue.  Notably, Jonas Salk spent the last years of his life searching for a vaccine against AIDS.  Until there is a vaccine, the development of life-saving drugs has lessened fear of the disease.]

When I was growing up, polio was an omnipresent and very scary disease.  Every year, children and their parents received warnings from public health officials, especially in the summer.  We were warned against going to communal swimming pools and large gatherings where the virus might spread.

We saw images on TV of polio’s unlucky victims.  Even though TV images back then were in black and white, they were clear enough to show kids my age who were suddenly trapped inside a huge piece of machinery called an iron lung, watched over by nurses who attended to their basic needs while they struggled to breathe.  Then there were the images of young people valiantly trying to walk on crutches, as well as those confined to wheelchairs.  They were the lucky ones.  Because we knew that the disease also killed a lot of people.

So every summer, I worried about catching polio, and when colder weather returned each fall, I was grateful that I had survived one more summer without catching it.

I was too young to remember President Franklin D. Roosevelt, but I later learned that he had contracted polio in 1921 at the age of 39.  He had a serious case, causing paralysis, and although he was open about having had polio, he has been criticized for concealing how extensive his disability really was.

Roosevelt founded the National Foundation for Infantile Paralysis, and it soon became a charity called the March of Dimes.  The catch phrase “march of dimes” was coined by popular actor/comedian/singer Eddie Cantor, who worked vigorously on the campaign to raise funds for research.  Using a name like that of the well-known newsreel The March of Time, Cantor announced on a 1938 radio program that the March of Dimes would begin collecting dimes to support research into polio, as well as to help victims who survived the disease. (Because polio ultimately succumbed to a vaccine, the March of Dimes has evolved into an ongoing charity focused on the health of mothers and babies, specifically on preventing birth defects.)

Yes, polio was defeated by a vaccine.  For years, the March of Dimes funded medical research aimed at a vaccine, and one of the recipients of its funds was a young physician at the University Of Pittsburgh School Of Medicine named Jonas Salk.

Salk became a superhero when he announced on April 12, 1955, that his research had led to the creation of a vaccine that was “safe, effective, and potent.”

Salk had worked toward the goal of a vaccine for years, especially after 1947, when he was recruited to be the director of the school’s Virus Research Laboratory.  There he created a vaccine composed of “killed” polio virus.  He first administered it to volunteers who included himself, his wife, and their children.  All of them developed anti-polio antibodies and experienced no negative reactions to the vaccine. Then, in 1954, a massive field trial tested the vaccine on over one million children between six and nine, allowing Salk to make his astonishing announcement in 1955.

I remember the day I first learned about the Salk vaccine. It was earthshaking.  It changed everything.  It represented a tremendous scientific breakthrough that, over time, relieved the anxiety of millions of American children and their parents.

But it wasn’t immediately available.  It took about two years before enough of the vaccine was produced to make it available to everyone, and the number of polio cases during those two years averaged 45,000.

Because we couldn’t get injections of the vaccine for some time, the fear of polio lingered.  Before I could get my own injection, I recall sitting in my school gym one day, looking around at the other students, and wondering whether I might still catch it from one of them.

My reaction was eerily like John Kerry’s demand when he testified before a Senate committee in 1971:  “How do you ask a man to be the last man to die in Vietnam?”  I remember thinking how terrible it would be to be one of the last kids to catch polio when the vaccine already existed but I hadn’t been able to get it yet.

I eventually got my injection, and life changed irreversibly.  Never again would I live in fear of contracting polio.

In 1962, the Salk vaccine was replaced by Dr. Albert Sabin’s live attenuated vaccine, an orally-administered vaccine that was both easier to give and less expensive, and I soon received that as well.

(By the way, neither Salk nor Sabin patented their discoveries or earned any profits from them, preferring that their vaccines be made widely available at a low price rather than exploited by commercial entities like pharmaceutical companies.)

Today, confronting the Covid-19 virus, no thinking person can avoid the fear of becoming one of its victims.  But as scientists and medical doctors continue to search for a vaccine, I’m reminded of how long those of us who were children in the 1950s waited for that to happen.

Because the whole world is confronting this new and terrible virus, valiant efforts, much like those of Jonas Salk, are aimed at creating a “safe, effective and potent” vaccine.  And there are encouraging signs coming from different directions.  Scientists at Oxford University in the UK were already working on a vaccine to defeat another form of the coronavirus when Covid-19 reared its ugly head, and they have pivoted toward developing a possible vaccine to defeat the new threat.  Clinical trials may take place within the next few months.

Similarly, some Harvard researchers haven’t taken a day off since early January, working hard to develop a vaccine.  Along with the Center for Virology and Vaccine Research at the Beth Israel Deaconess Medical Center, this group plans to launch clinical trials in the fall.

While the world waits, let’s hope that a life-saving vaccine will appear much more quickly than the polio vaccine did.  With today’s improved technology, and a by-now long and successful history of creating vaccines to kill deadly viruses, maybe we can reach that goal very soon.  Only then, when we are all able to receive the benefits of an effective vaccine, will our lives truly begin to return to anything resembling “normal.”

A Day Without a Drug Commercial

Last night I dreamed there was a day without a drug commercial….

When I woke up, reality stared me in the face.  It couldn’t be true.  Not right now.  Not without revolutionary changes in the drug industry.

Here are some numbers that may surprise you.  Or maybe not.

Six out of ten adults in the U.S. take a prescription medication.  That’s up from five out of ten a decade ago.  (These numbers appeared in a recent study published in the Journal of the American Medical Association.)

Further, nine out of ten people over 65 take at least one drug, and four out of ten take five or more—nearly twice as many as a decade ago.

One more statistic:  insured adults under 65 are twice as likely to take medication as the uninsured.

Are you surprised by any of these numbers?  I’m not.

Until the 1990s, drug companies largely relied on physicians to promote their prescription drugs. But in 1997, the Food and Drug Administration revised its earlier rules on direct-to-consumer (DTC) advertising, putting fewer restrictions on the advertising of pharmaceuticals on TV and radio, as well as in print and other media.  We’re one of only two countries–New Zealand is the other one–that permit this kind of advertising.

The Food and Drug Administration is responsible for regulating it and is supposed to take into account ethical and other concerns to prevent the undue influence of DTC advertising on consumer demand.  The fear was that advertising would lead to a demand for medically unnecessary prescription meds.

It’s pretty clear to me that it has.  Do you agree?

Just look at the statistics.  The number of people taking prescription drugs increases every year.  In my view, advertising has encouraged them to seek drugs that may be medically unnecessary.

Of course, many meds are essential to preserve a patient’s life and health.  But have you heard the TV commercials?  Some of them highlight obscure illnesses that affect a small number of TV viewers.  But whether we suffer from these ailments or not, we’re all constantly assaulted by these ads.  And think about it:  If you feel a little under the weather one day, or a bit down in the dumps because of something that happened at work, or just feeling stressed because the neighbor’s dog keeps barking every night, might those ads induce you to call your doc and demand a new drug to deal with it?

The drug commercials appear to target those who watch daytime TV—mostly older folks and the unemployed.  Because I work at home, I sometimes watch TV news while I munch on my peanut butter sandwich.  But if I don’t hit the mute button fast enough, I’m bombarded by annoying ads describing all sorts of horrible diseases.  And the side effects of the drugs?  Hearing them recited (as rapidly as possible) is enough to make me lose my appetite.  One commercial stated some possible side effects:  suicidal thoughts or actions; new or worsening depression; blurry vision; swelling of face, mouth, hands or feet; and trouble breathing.  Good grief!  The side effects sounded worse than the disease.

I’m not the only one annoyed by drug commercials.  In November 2015, the American Medical Association called for a ban on DTC ads of prescription drugs. Physicians cited genuine concerns that a growing proliferation of ads was driving the demand for expensive treatments despite the effectiveness of less costly alternatives.  They also cited concerns that marketing costs were fueling escalating drug prices, noting that advertising dollars spent by drug makers had increased by 30 percent in the previous two years, totaling $4.5 billion.

The World Health Organization has also concluded that DTC ads promote expensive brand-name drugs.  WHO has recommended against allowing DTC ads, noting surveys in the US and New Zealand showing that when patients ask for a specific drug by name, they receive it more often than not.

Senator Bernie Sanders has repeatedly stated that Americans pay the highest prices in the world for prescription drugs.  He and other Senators introduced a bill in 2015 aimed at skyrocketing drug prices, and Sanders went on to rail against them during his 2016 presidential campaign.

Another member of Congress, Representative Rosa DeLauro (D-Conn.), has introduced a bill specifically focused on DTC ads.  Calling for a three-year moratorium on advertising new prescription drugs directly to consumers, the bill would freeze these ads, with the aim of holding down health-care costs.

DeLauro has argued, much like the AMA, that DTC ads can inflate health-care costs if they prompt consumers to seek newer, higher-priced meds.  The Responsibility in Drug Advertising Act would amend the current Food, Drug, and Cosmetic Act and is the latest effort to squelch DTC advertising of prescription meds.

The fact that insured adults under 65 are twice as likely to take prescription meds as those who are not insured highlights a couple of things:  That these ads are pretty much about making more and more money for the drug manufacturers.  And that most of the people who can afford them are either insured or in an over-65 program covering many of their medical expenses.  So it’s easy to see that manufacturers can charge inflated prices because these consumers are reimbursed by their insurance companies.  No wonder health insurance costs so much!  And those who are uninsured must struggle to pay the escalating prices or go without the drugs they genuinely need.

Not surprisingly, the drug industry trade group, the Pharmaceutical Research and Manufacturers of America, has disputed the argument that DTC ads play “a direct role in the cost of new medicines.”  It claims that most people find these ads useful because they “tell people about new treatments.”  It’s probably true that a few ads may have a public-health benefit.  But I doubt that very many fall into that category.

Hey, Big Pharma:  If I need to learn about a new treatment for a health problem, I’ll consult my physician.  I certainly don’t plan to rely on your irritating TV ads.

But…I fear that less skeptical TV viewers may do just that.

So please, take those ads off the air.  Now.

If you do, you know what?  There just might be a day without a drug commercial….

 

[The Wellness Letter published by the University of California, Berkeley, provided the statistics noted at the beginning of this post.]