Why Big Pharma Gets A Bad Reputation

I used to be the darling of the pharmaceutical industry.  They gave me contracts to test their new drugs.  They hired me to travel the country and speak at meetings of medical groups. I don’t think their current opinion is quite so flattering.  I’m often asked, “Why do you hate prescription drugs? Why are you against drug companies?”  And the answer is, “I’m NOT!”  I strongly believe in using prescription drugs made by legitimate pharmaceutical companies in certain cases.  In fact, I insist on it.  If a patient who is aware of my facility in using natural treatments could do better with a prescription, that’s what I advise. If they refuse, I may decide to work with them on a second-best treatment, if it doesn’t run risk of serious illness or death. Otherwise, I tell them to find somebody else to give them natural treatments. I won’t risk their health or life.  What I oppose is the politics involved with pharmaceutical companies and some of the things they have done.

Medical Schools:

• Companies have been caught and fined for writing papers and giving them to college professors who can get them published under their own names in peer-reviewed journals. This not only helps the professor who needs to “publish or perish” to get tenure (or at least advancement) but it gives the drug company a legitimacy they cannot get themselves.  Oh, and the presentation of the research paper to the professor often includes a financial honorarium. When they get caught, the drug companies are fined, reprimanded, sent to bed without dessert.
• Medical students, residents and fellows who earn a pittance while undergoing expensive training are often treated to simple things like meals, and sometimes by more expensive things. They naturally develop a feeling of gratitude toward the company.  Universities – especially in these times of diminished federal and state allotments – earn a substantial portion of their budget from clinical trials sponsored by pharmaceutical companies.
• Budgeting — If a company should withdraw it’s support, many universities would have to either fold or substantially cut back their programs.

 

Medical Journals: The majority of advertising in the major medical journals consists of – can you guess? – Pharmaceutical Companies. If any journal should dare to publish an article that states that some natural treatment is as good or better than a prescription drug, or if an article points out any way the clinical tests were skewed, the advertising would be discontinued and the magazine would be in serious trouble – or fold.

Government: There are 300 lobbyists representing various medical industries – insurance, pharmaceutical, appliances, etc — for each Senator.  These lobbyists can present pre-written bills for a legislator to introduce (and take full credit for) that will benefit the drug companies.  And in many cases, those lobbyists are former members of Congress who shaped laws that benefited the industry they joined.  One result is that there are strict laws about how natural treatments may be used, described or even mentioned.

From The Boston Globe,  December 12, 2003

The White House yesterday categorically refused to answer questions about why President Bush’s longtime business associate was allowed to “craft” key portions of the Medicare bill which could send millions to his own company.

The Boston Globe reports a Texas company owned by David Halbert “a campaign contributor and former business associate of President Bush” could profit from portions of the Medicare bill.

The Globe notes the story was first reported in yesterday’s Progress Report and points out that Halbert specifically helped “craft the portion of the Medicare bill that allows seniors to buy discount drug cards.” Bush had been an investor in a Halbert-owned predecessor company to AdvancePCS, which, “is one of the nation’s largest pharmacy benefit management companies and would be well-positioned to compete for Medicare’s endorsement to issue the discount cards.”

Of course, the discount card guarantees no discount – only that companies like AdvancePCS (of which President Bush was an original investor) would gain millions of new customers.

Sen. Edward Kennedy said, “Only in this administration would the words `discount card’ mean seniors get the card while corporations get the discounts.”

When asked about the controversy, the White House invoked a line similar to its previous stonewalling about which oil industry CEOs wrote its energy bill. Said White House spokesman Trent Duffy, ”I’m not going to be able to say anything about specific conversations the White House had in crafting this legislation.” 

It’s no wonder that many doctors – so called “legitimate doctors” with medical school degrees and licenses to practice medicine in many states – have come to view pharmaceutical companies with a healthy skepticism.  Then again, the public becomes aware of such things as they enter popular entertainment.  When I had my radio show in Oklahoma City in the 1990s, I occasionally did a psychiatric movie review.  I would take a current movie and criticize it – not on the quality of acting, or  the script or directing – but based on how realistic the treatment was, the ethics of the practitioner, and the other various technical aspects that audiences probably didn’t really care about but that I thought was instructive.  Some of the big ones I remember (and some from later dates than my radio show).

The Fugitive (1993)My engineer begged me for weeks to review this TV series re-make with Harrison Ford as the doctor wrongly accused of the murder of his wife. It turns out that the wife – a drug researcher – found out that the drug she was working with was fatally flawed and the manufacturer was covering up the problem.  She was murdered by Big-Pharma hit men and Harrison was framed.
Kids in the Hall: Brain Candy (1996)was a special favorite because it was just plain silly and engineered to be so. Apparently some pharmaceutical company has developed a happy drug (Gleemonix) that makes you feel “like God is rubbing your tummy.” Echoing real life, the drug is rushed into production. But soon, the clinical trials subjects start to become catatonic. OOOPS!  The drug is a big success and people are taking it like candy – Brain Candy! The head of the drug company is the type of guy to make lemonade out of lemons.  Among the plans he makes are monetary compensation to victims and – best of all — a “Miss Coma” beauty contest.
The Constant Gardner (2005) is one of the grimmest of the lot, based on a novel by espionage superstar John Le Carre’.  The film tells about a (fictional) Amnesty International activist’s battle against drug companies who plan to test their new drugs on African villagers who don’t know what they are getting. The subjects start dying, but their fate is met with callousness by the drug company.  The company line is, “We’re not killing people who wouldn’t be dead otherwise.” Another character in the movie states, “Big pharmaceuticals are right up there with the arms dealers.”  Of course, the Amnesty International activist is murdered by — you guessed it — Big Pharma Hit men.

Factor 8: The Arkansas Prison Blood Scandal (2005) is a chilling film that gets its power from being an account of actual events (which none of the above are, I want to stress). A prisoner blood donor program in Arkansas during the tenure of Gov. Bill Clinton and discovered during the administration of Pres. Bill Clinton allowed Hepatitis C and AIDS patients to “slip through the cracks” (the implication is “accidentally on purpose”). This tainted blood made its way into the pharmaceutical manufacturing process and the product – Factor 8 — was sold to patients in Canada, Asia and Europe. This went on for about 20 years. The result was criminal investigations and class-action suits in Canada, Europe and Japan that are still dragging through the courts. This story has been hushed up – have you ever heard of it before now?

I’ve already written about Polyheme, a blood substitute that was given to trauma victims who were unable to give informed consent, in collusion with the city of San Diego, EMT services and the university getting paid to collect data on the results.  The program was exposed by an investigative journalist and caused much embarrassment but I don’t know that anything came of it. Oh yeah, Polyheme was a failure, and the people who got it did worse than people who had real blood transfusions (which probably means they died, since they were in such bad shape to begin with).

SO .. .ON WITH TODAY’S STORY–

I think I’ve probably established more than enough reasons why I’m not the strongest booster of the big multi-national pharmaceutical corporations – although I’m not against using prescription drugs when indicated. This will tell you the reason that the administrator of a clinic where I came in to review (and hopefully make some positive adjustments to) clinical operations asked me if I want to see any representatives of drug companies. I told her I was so busy I would have little time, but I had not yet physically assaulted any drug reps, so there was probably no danger. I expected a laugh, but did not get one. I told her I thought that drug companies were so clearly on a direction of maximizing profits without any particular regard for health benefits — and sometimes, I thought, getting some things past the FDA that ought not to be gotten past the FDA — that I really doubted any discussion that I had with a drug rep would be terribly productive. However, most major companies have what they call “compassionate programs” which will pay for prescriptions for patients who meet financial criteria (low income, unemployment, dependent children, etc) and also companies love to dish out free samples – at least until a drug gets “launched” and then they no longer give samples.

Many of the people who seek help in clinics like the one I happened to be at are not financially able to purchase the drugs that could help them.

Me, I don’t tell these people that if they are using their money on things like marijuana and fancy synthetic nails, maybe they don’t deserve free drugs. I think that part of my job is supposed to include suspending judgment on human wisdom. Then I got an email about a big luncheon party, launching a “brand  new” psychotropic. Better than usual free food?  Well, they did have a rather rich avocado sauce for the characteristically dry chicken served at these things. (NOTE: the chicken never improves, no matter where in the nation I’ve sampled it.) And the beans  were not over-spiced. Most of the therapists present knew the stereotypical drug rep, who had previously represented three other companies.  I guess by now, the rep knew the territory and the personnel.

I might point out that the majority of the people at this luncheon could not prescribe medication (being therapists of various sorts) but were so burned out by working at this over-crowded, under-staffed and under-funded clinic that they  welcomed any diversion such as a free lunch.

The drug presented at this luncheon meeting was Oleptro and it is NOT a new drug. It is a diazolopyridine, or tetracyclic, serotonergic antidepressant that was in use when I was a beginning psychiatry resident, back in the late 80s. Every single one of my preceptors had told me, and as rarely happened, they were all correct, that this drug, Trazodone, was such a God-awful pain in the neck that we should use other things and not bother with it. Later, people discovered a side-effect — small amounts of it could help people sleep. But even then, this drug did such a good job of whomping people that sometimes they did not even want it for sleep, because it was too hard waking up in the morning. Now — because someone had come up with a time release kind of micro-engineering to keep the blood level more stable — all problems had magically disappeared, and this was a “new” antidepressant. We knew long ago it was an effective antidepressant only if you could stuff enough of it into a patient without them tipping over from low blood pressure to do the trick. This drug has one other major problem, however. — It causes priapism. Of course, when I warn the patient that a possible side-effect in about 1 of 1000 gentlemen is a permanent erection.  This always results in chuckling and winking and assurances that this might not be such a drawback, little missy.

Yeah, the male ego seems to think that it would be desirable to have a sustained and painful erection — but it isn’t. The pain is so horrible that the males so afflicted need to go to an emergency room for an injection to “bring things down.” Unfortunately, sometimes, things will NEVER get up again. I would say that in my VA career, where Trazodone was frequently used for sleep, and sometimes patients increased the dosage of the prescription beyond any good sense, I have seen approximately twelve gentlemen so afflicted, and there were FAR fewer than 12,000 patients taking this drug. 

And when I saw them – without exception – they were in tears.

So much for the “macho side-effects” (Wink Wink). One of whom I remember with special feeling was a victim of such treatment who fell crying into my arms, telling me he felt he was no longer a man because he could not satisfy the woman he still loved, and yet she remained with him. Before we had Viagra, I remember some doctors in the Midwest used Trazodone to help men achieve erection.  I compare this to a doctor in ancient Egypt prescribing Cleopatra to sleep with an asp to cure her insomnia. At this particular luncheon, one of the few other psychiatrists present asked about priapism, and was told this did not happen with the new preparation. Since Oleptra used a delayed-release formula to keep the blood levels more even – no problem. Now every single mechanism for time release, including this one — that I have ever heard of — is similar. It has something to do with microspheres of various sizes, just like Contac’s “tiny little time pills.” Now I absolutely could not see how time-releasing some tiny little time pills of Trazadone could affect the two most worrisome side effects — low blood pressure and priapism. Well, the drug rep (whom I had warned I was a pain in the neck) couldn’t tell us, except that these side effects did not show up in the only two clinical trials from the FDA required.

So I asked the question — 200 people in the trial. How many were male?

The answer was 27%, or 54 males out of 200 subjects. Now from the older studies I happen to know that the odds of priapism were about one in one thousand patients – MALE patients, of course.  In some studies, it was less frequent.

So, assuming that you know so little about statistics that you think that you have to give the drug to 1000 males before turning up priapism – the test fell short by about 950 patients. Testing on women is seldom used because of the danger of a subject getting pregnant and having a child with birth defects.  So why did this company decide to use four times as many women as men in their trial?

I can only guess, but nobody has convinced me this “new” drug will not cause priapism. I am a married woman and I think men are wonderful and I think one of 1000 men who does not feel like a complete man and does not have the ability to satisfy sexually someone he cares about is one too many. I have never started a male on Trazodone, and I am not going to start doing this just because it has tiny time pills. This new drug, Oleptro, is an affront to the common sense of any semi-literate practicing physician or psychiatrist. All the test tells me is that I suppose I can give it to women in some cases.  However, in my 30 years of experience, it is about 20^thon the list of prescription drugs I would give a woman suffering from depression. However, it still has the slight chance of causing low blood pressure problems – even with women, as long as they aren’t taking anything else. That’s because it is metabolized in the same pathway – the CYP4A5 system if you are interested — which means lots of drugs will have interactions with it.  Side effects – possibly bad side effects – from things like blood pressure medicine, diabetes medicine, perhaps birth control pills or acne medicine.  It’s a pretty common drug pathway – you really have to be careful when getting into these things (which is my specialty as a psychopharmacologist). Although samples would be given, I was told this drug has no compassionate care program. That means this company — who brought this to market very cheaply since the base drug was already approved by the FDA — will NOT provide it long-term free to deserving poor folks. The drug rep, to his credit, admitted it would probably not be a first line treatment choice. I did tell the rep that since development had been so cheap, a program of compassion for poor folks was definitely indicated. He said he would take the info back to the company (Feh!) I told him this product should be sampled liberally. He promised to empty his sample kits out of his garage and bring them to the clinic’s free drugs for poor folks room. The company that makes this drug is going to apply their time release technology to other things, probably drug combinations. The drug rep seemed excited about this. I was not.  This is the clearest example I have ever seen of minimizing investment in drug development to create maximal profit.

• There is no added advantage to the patient or to the clinician.
• There is no advantage to either pharmacology or psychiatry.
• There is a real risk of side effects emerging that were not present in premarketing studies because these serious side effects already have emerged in earlier use of the drug.

The people in this company are basically manipulating existing products that work perfectly well with creating additional value.  For a minimal investment they end up with a product to which they can apply all sorts of aggressive marketing techniques.

You would think they would recognize the PR value of dishing out some free pills to the needy.

They are not selling toys or widgets here. They are selling a chemical that that might help with the devastating illness of depression, something numerous already existing chemicals do help with. Sure, it might run down blood pressure a little. Sure it might mean a permanent end to male sexuality for an unlucky few, thus giving them a serious reason to be depressed. Although there is nothing illegal about what they are doing, and the American Way approves of a company making an honest profit – some of these practices border on profiteering.

People are looking to squeeze more and more profit out of existing  products by wrapping them in new names and snappy marketing techniques.

Gone are the days of new drug development, seeking to make better products, safer products, less expensive products.

We must look to other solutions.

Other countries have other forms of regulation and development.  Our own FDA has been compromised by the drug companies and by government meddling,  the best thing might be to scrap it and start from zero. Maybe this will help someone see natural solutions, that are cheaper and effective. But not this. Not even with chicken with avocado sauce for lunch.