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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ViiV Employs Patient Ambassadors to Start in First Branded (Triumeq) TV Ads for HIV Treatment - Warning Card Included!

ViiV Employs Patient Ambassadors to Start in First Branded (Triumeq) TV Ads for HIV Treatment - Warning Card Included! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

GlaxoSmithKline's ViiV Healthcare is taking its dedicated history in HIV treatment and community involvement to the small screen. New TV advertising for its HIV fighter Triumeq features five people living with HIV talking about their diagnoses and treatment, as well as images showing how they’re “Moving Forward.”

It may also be a first for an HIV drug; while HIV awareness ads have aired on TV before, no other branded HIV drugs, at least in recent history, have aired TV spots. Healthcare professionals, advocates and people living with HIV have been asking ViiV for some time why they weren’t advertising on TV, Andrew Perry, ViiV VP of marketing in the U.S., said in an email interview.

“Given the importance of presenting realistic, positive images of the life a person being treated for HIV can lead, we felt like it was the right time to broaden our approach,” he said. “… We felt that now more than ever we must present a realistic, modern view of what the life of a person living with HIV can look like if their HIV is appropriately treated—and to do that on television for the first time. Reaching some people living with HIV can also be difficult, so television advertising is one more way to broaden our reach to help ensure no one living with HIV is left behind."

Some of the people who star in the TV spot already appear in other media for Triumeq. ViiV also used an organization that connects patients with companies looking for ambassadors and advocates, Perry said, acknowledging the “brave step” these patients have taken.

“Appearing on TV is a daunting commitment, and publicly disclosing their HIV status in a national TV campaign required an amazing level of bravery for each of our ambassadors. We are so grateful for their courage in sharing their status and their journey,” he said.

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How Gilead Manipulates HIV Drug Patents at the Expense of Patient Safety & Affordability

How Gilead Manipulates HIV Drug Patents at the Expense of Patient Safety & Affordability | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Gilead Sciences won a victory last week when a federal court judge tossed a lawsuit in which an AIDS activist group accused the drug maker of manipulating the patent system in order to thwart competition for its HIV medicines.

 

At issue was tenofovir, or TDF, which until recently had been a cornerstone of the widely used combination HIV treatments sold by the company. The patent on the TDF compound expires in December 2017, and Gilead is replacing it with a modified version known as TAF. But the patent on TAF doesn’t expire until May 2022, providing another five valuable years without generic competition.

 

TAF is also more potent and causes fewer side effects, notably bone damage and kidney toxicity. AHF argued Gilead knew of the safety benefits dating back to 2001, but the company delayed testing TAF in humans until 2011. In doing so, AHF charged Gilead purposely waited to seek regulatory approval for drugs containing TAF until shortly before its older TDF-based products lost patent protection.

 

This maneuvering meant that Gilead would be able to forestall patent challenges on its TAF-based drugs for a few years, but meanwhile, HIV patients faced side effects unnecessarily. Moreover, AHF maintained that since TAF is simply a modified form of TDF, the drug maker does not deserve patent protection and sought to have the TAF patents invalidated.

 

But in a ruling last Wednesday, Judge William Alsup of the US District Court in San Francisco shot down the arguments made by the nonprofit, which buys medicines for the 46 health centers it operates in the United States. “Gilead’s patents gave it a monopoly over both TDF and TAF. It had no obligation to introduce the improved product at an earlier date,” he wrote.

           

The decision, by the way, came less than a week after Gilead raised prices on two older HIV medications — Complera and Stribild — that contain TDF and face patent expiration. In fact, it was the second time in six months the company boosted list prices — which do not reflect rebates offered payers — a break from its usual strategy of increasing prices annually.

 

At the same time, Gilead left intact prices for two much newer versions of these drugs — Odefsey and Genvoya — which contain TAF. And these newer medicines are now priced higher than the older treatments. AIDS activists criticized the company for raising payer and patient costs.

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Gilead, Support Your "Truvada Whores!" HIV activists target Gilead for holding back on Truvada marketing

Gilead, Support Your "Truvada Whores!" HIV activists target Gilead for holding back on Truvada marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Gilead Sciences is no stranger to criticism. Consider the years-long outcry over HIV and hep C drug prices. But now the California-based company finds itself in a strange--yet somehow familiar--spotlight. At a time when the pharma industry is drawing fire for marketing its drugs to doctors, Gilead is drawing fire for not marketing enough.


The issue is Truvada, Gilead's HIV treatment that's also approved to prevent infection with the virus. It's the only drug blessed by the FDA for that use. It's backed by the U.S. Centers for Disease Control and Prevention (CDC) for pre-exposure prophylaxis, or PrEP.


But more than two years after that much-publicized approval, a year after the CDC recommended its routine use, few at-risk people are actually taking Truvada. In fact, as Bloomberg reports, only 3,200 Truvada scripts were written for prevention through March 2014.


Gilead "does not view PrEP as a commercial opportunity and is not conducting marketing activities around Truvada as PrEP," spokeswoman Cara Miller told the news service.

Pharma Guy's insight:


Gilead, however, needs to go beyond a drug.com website to get the message out. In fact, this sounds like a problem tailor-made for a mass-media (TV and print) direct-to-consumer advertising solution! But Gilead has no plans to advertise Truvada for prophylaxis, even though the FDA approved it for that use back in 2012.

Why not?

Not advertising helps Gilead avoid controversy, but I contend that in this case not advertising is itself controversial considering that Truvada is 99% effective in preventing HIV infection and that based on the "number needed to treat" data, Truvada is FOUR TIMES more likely to save lives than statins, another widely promoted preventive drug regimen (see chart above).

If Gilead decides to advertise Truvada for prophylaxis, I have some recommendations. Find them here.

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High Cost, Lack of DTC Advertising, & Physician Unawareness are Major Factors for Truvada’s Failure

High Cost, Lack of DTC Advertising, & Physician Unawareness are Major Factors for Truvada’s Failure | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Although Truvada was approved as a preventive drug four years ago, less than one-tenth of those who could benefit from it take the drug [Meanwhile, “Grindr Poll Says 25% of Gay Men Taking Truvada”; http://sco.lt/70Mnqb]. The need is greatest among blacks and Latinos, who are disproportionately affected by AIDS, and gay men under 30, whose rates of infection are growing.

 

Also known as PrEP — for post-exposure prophylaxis — the medicine serves as a backstop to other methods of avoiding infection for those who are at high risk. It’s considered one of the most significant advances in the fight against AIDS.

 

Critics questioned the wisdom of giving powerful drugs to healthy people, and worried that access to a preventive drug would encourage promiscuity or lead to a spike in other sexually transmitted diseases by reducing condom use.

 

In 2012, the first year PrEP was on the market, only 6,210 people nationwide started the drug, according to data from Truvada’s maker, Gilead Sciences. By the end of 2015, more than 79,000 people had started PrEP since the regimen was introduced.

 

What’s the problem?

 

Primary care doctors often don’t know enough about PrEP to feel comfortable offering it. [Read, for example, “Lack of DTC Advertising Means Many Doctors Unaware of Truvada, Drug for Preventing H.I.V.”; http://sco.lt/6XYebR ]

 

Another challenge is the commitment required: In addition to taking a daily pill, patients must come back every three months to test for HIV and other sexually transmitted diseases, and to check for kidney problems, an uncommon but serious side effect.

 

And cost can be an obstacle. The list price for the drug is $1,500 a month, although most insurers negotiate discounts.

 

Pharma Guy's insight:

Gilead did not begin direct-to-consumer advertising of Truvada until January, 2016 (http://bit.ly/2bUyr8q - I'm happy to see that Gilead may have followed my recommendations. Find them here: http://bit.ly/1AGU2ZY).

 

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Cash Payments Fail to Improve Adherence - at Least for HIV Drugs. But Wow!

Cash Payments Fail to Improve Adherence - at Least for HIV Drugs. But Wow! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Scientists at an AIDS conference in Seattle said paying patients as much as $280 a year to take AIDS-prevention drugs failed to significantly improve adherence or infection rates.


The hope was that the drugs would not only improve the health of the people taking them, but help slow the spread of H.I.V. infections. H.I.V. patients who take their medicine regularly are about 95 percent less likely to infect others than patients who do not. The Centers for Disease Control and Prevention estimates that only a quarter of all 1.1 million Americans with H.I.V. are taking their drugs regularly enough to not be infectious.


Paying patients $25 to take H.I.V. tests, and then $100 to return for the results and meet a doctor, also failed, the study found.

“We did not see a significant effect of financial incentives,” said Dr. Wafaa M. El-Sadr, an AIDS expert at Columbia University and the lead investigator. But, she said, there is “promise for using such incentives in a targeted manner.”


Cash payments might still work for some patients and some poor-performing clinics, she said.


Other H.I.V.-prevention research released here Tuesday offered good news for gay men but disappointing results for African women.


Two studies — both of gay men, one in Britain and the other in France — confirmed earlier research showing that pills to prevent infection can be extremely effective if taken daily or before and after sex. Both were stopped early because they were working so well that it would have been unethical to let them continue with men in control groups who were not given the medicine.


But a large trial involving African women of a vaginal gel containing an antiviral drug failed — apparently because 87 percent of the women in the trial were unable to use the gel regularly.


The failure of the cash-incentives trial was a surprise and a disappointment to scientists and advocates. It had paid out $2.8 million to 9,000 patients in 39 clinics over three years, but the clinics where money was distributed did only 5 percent better than those that did not — a statistically insignificant difference.

Pharma Guy's insight:


Obviously, this is a blow to companies like HealthPrize whose business model is awarding prizes to patients who are adherent. Read  Eyes on the Adherence Prize: How HealthPrize Uses Financial Incentives and Fun to Change Patient Behavior.


But there are a lot of reasons why $ didn't work in this case. For one thing, the drugs appear to be for prevention of infection or that may be how they were presented to patients. If you don't have symptoms, why take a drug with potentially dangerous side effects, especially if it is difficult to use?

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Fire in the Blood: Will History Repeat Itself re Ebola Vaccine? See the Movie.

Fire in the Blood: Will History Repeat Itself re Ebola Vaccine? See the Movie. | Pharmaguy's Insights Into Drug Industry News | Scoop.it
When big pharma blocks essential HIV/AIDS medication to the third world, it is the poor who suffer.


The award-winning documentary Fire in the Blood exposes the challenges NGOs, doctors and activists face in their fight against big pharma and patent laws that prevent millions of HIV/AIDS patients in the developing world from accessing lifesaving drugs.


Oscar winner William Hurt narrates the documentary which was shot in eight countries, across four continents.


The film's contributors include Bill Clinton, Desmond Tutu and Nobel laureate economist Joseph Stiglitz, along with key figures in the struggle to get essential HIV/AIDS drugs to countries of the global south.


Fire in the Blood will screen in two parts on Al Jazeera English on October 31 and November 7, 2014.

Pharma Guy's insight:


I know that pharma companies such as Johnson & Johnson have pledged hundreds of millions of dollars to ratchet up their Ebola vaccine research (see, for example, J&J to spend up to $200 million in push to speed up potential Ebola vaccine development), but there is no pledge that once developed they will donate the vaccine to poor countries in Africa. That's why I ask if history will repeat itself.

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